FDA cleared a unique pediatric HIV-1 medication in dispersible tablet formulation.

Dolutegravir (Tivicay PD, ViiV Healthcare) tablets for oral suspension are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients.

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“For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults,” said Debra Birnkrant, MD, director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research, in a 

. “While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV.”

Patients taking the drug must be treatment-naïve (or -experienced but INSTI- naïve), at least 4 weeks old, and weigh at least 3 kg. Viiv also received an extended indication to expand the use of the already approved Tivicay 50 mg film-coated tablet in paediatric HIV patients weighing 20 kg and above.

Tivicay is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as 4 weeks of age and weighing at least 3 kg, Viiv said in a 

. Prior to this, dolutegravir was indicated in the US for children from 6 years of age and weighing more than 30 kg.

“This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children,” ViiV said.

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“I am delighted that our innovative approach to science has enabled us to achieve FDA approval of the first-ever dispersible tablet formulation of dolutegravir, now making it easier for young children to take this medication by dispersing the tablet in water,” ViiV CEO Deborah Waterhouse said. "The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age and as they grow.”

There are 1.7 million children living with HIV1, and the majority of AIDS-related deaths among children still occur during the first 5 years of life, ViiV said. “Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals,” the pharma maker said.

The safety and effectiveness of Tivicay and Tivicay PD were supported by a trial that included 75 HIV-1–infected infants, children and adolescents 4 weeks to less than 18 years old. At 24 weeks, 62% of pediatric patients taking Tivicay or Tivicay PD had an undetectable viral load (the presence of virus in the blood) and at 48 weeks, 69% had an undetectable viral load, FDA said.

Also, on average, study subjects had higher levels of certain cells (CD4 cells) that help the body fight off infection.

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Articles

The unique formulation is a dispersible tablet for children.

New pediatric HIV med available

Five pharma makers are recalling their extended-release metformin tablets due to high levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA).

 its testing found “certain extended release metformin products contain NDMA above the acceptable level.”

Two metformin products recalled, more on the way

Soon after Apotex Corp and Amneal Pharmaceuticals 

 their metformin hydrochloride extended-release tablets, Teva Pharmaceuticals and Marksans Pharma Limited, India have issued recalls. The fifth manufacturer has not been named by the FDA.

 14 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, as well as 100 and 1000-count bottles.

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 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, lot #XP9004.

 all lots of metformin hydrochloride extended-release tablets, USP, 500 mg and 750 mg, within expiry to the retail levels. The affected products were distributed nationwide in the US directly to wholesalers, distributors, retailers, and repackaers.

Apotex Corp is recalling all lots of metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to retail level. However, Apotex stopped selling this product in the U.S. in February 2019, and there remains only a limited amount on the market, it said in a 

Pharma maker recalls drug over undeclared anti-hypertensive drug

Five pharma markers are recalling the diabetes medication due to the presence of a carcinogenic ingredient.

Major Metformin recalls underway

The U.S. government's current supply of remdesivir will run out at the end of this month, CNN 

The amount of people who need the medication outnumbered the supply by a 2-to-1 ratio, according to 

. Gilead Sciences and the Department of Health and Human Services distributed remdesivir for between 40,000 and 74,000 hospitalized patients.

The government’s last shipment of remdesivir will go out the week of June 29, Robert Kadlec, MD, assistant secretary for preparedness and response at HHS, told CNN.

"Right now, we're waiting to hear from Gilead what is their expected delivery availability of the drug as we go from June to July," Kadlec said. "We're kind of not in negotiations, but in discussions with Gilead as they project what the availability of their product will be,” Kadlec said.

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"Whatever the supply may be, there may not be enough for everyone who may need it,” he added.

However, the government has been working to help Gilead "with some of their supply chain challenges in terms of raw materials and being able to accelerate the process,” Kadlec told CNN.

 to have more than 500,000 remdesivir treatment courses available by October, and more than a million by December.

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HHS says supply could run out by the end of this month.

Remdesivir for COVID-19 in short supply

FDA cleared imipenem-cilastatin and relebactam (Recarbrio, Merck)

to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. 

Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options. The drug is administered intravenously by a healthcare professional.

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“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” said Sumathi Nambiar, MD, MPH, director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research. In a 

. “These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”

The safety and efficacy of Recarbrio for the treatment of HABP/VABP were evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam (Tazocin, other brand names), another antibacterial drug. 

Overall, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.

The most common adverse reactions observed in patients treated with Recarbrio for HABP/VABP included increased aspartate/alanine aminotransferases (increased liver enzymes), anemia, diarrhea, hypokalemia (low potassium) and hyponatremia (low sodium).

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The agency welcomes another option for serious bacterial infections.

New antibiotic for hospital-acquired pneumonia available

FDA cleared ticagrelor (Brilinta, AstraZeneca) to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD).

“This is the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high CV [cardiovascular] risk, but without a history of heart attack or stroke,” AstraZeneca said in a 

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Brilinta is already approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS), and in more than 70 countries for the secondary prevention of CV events among high-risk patients who have experienced a prior myocardial infarction.

Brilinta’s expanded indication was based on positive results from a Phase 3 trial. The study showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus Brilinta 60 mg. versus aspirin alone in patients with CAD and type 2 diabetes (T2D) at high-risk of a first heart attack or stroke. 

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, was multi-national trial of 19,000 patients with coronary artery disease and type 2 diabetes.

“Around one-third of patients with coronary artery disease have type 2 diabetes, putting them at higher risk of heart attack or stroke than patients without diabetes. Today’s approval brings new hope to patients at risk of experiencing a first heart attack or stroke,” said Gabriel Steg, MD, the trial’s co-chair and professor at UniversitÃ© de Paris.

AstraZeneca also recently announced the 

 from the Phase III THALES trial, which showed aspirin plus Brilinta 90 mg. reduced the risk of the composite of stroke and death at 30 days after an acute ischemic stroke or transient ischemic attack, compared to aspirin alone.

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Brilinta is already approved to prevent atherothrombotic events in ASC.

Immediately after the FDA said it found elevated levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA) in certain extended release (ER) metformin products, the first 2 major recalls are underway.

Both Apotex Corp and Amneal Pharmaceuticals have issued a voluntary recall of metformin hydrochloride extended-release tablets, and FDA said three additional companies will recall their ER metformin.

Apotex Corp is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to retail level. However, Apotex stopped selling this product in the U.S. in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of that product, it said.

Amneal is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP, 500 mg and 750 mg, within expiry to the retail levels. The affected products were distributed nationwide in the US directly to wholesalers, distributors, retailers, and repackagers.

The agency’s testing found that “certain extended release metformin products contain NDMA above the acceptable level,” FDA said.

“FDA is contacting companies with ER metformin above the acceptable level and will continue to take quick and appropriate action when needed to protect American consumers. We are committed to providing timely updates on our investigations and any recalls,” FDA said.

The FDA said that patients should not stop taking their prescription medications without first talking to their healthcare providers.

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In early February, the agency posted the results of its laboratory analysis showing NDMA levels in some samples of the metformin products it tested. Overall, the levels of NDMA found in metformin ranged from “not detectable to low levels” at the time.

According to the agency, no sample of metformin that was tested by the FDA exceeded the acceptable daily intake of NDMA.

In December, regulatory agencies outside of the United States recalled some metformin drugs due to low levels of the impurity, prompting FDA officials to test samples of metformin sold in the US.

FDA cleared the only drug in the U.S. to treat severe malaria in adults and children. There has been no FDA-approved drug to treat severe malaria since the marketing of quinine was discontinued by the manufacturer in March 2019, the agency said in a 

FDA okayed IV artesunate (Amivas), which should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.

Previously, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the CDC  to provide IV artesunate to U.S. patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol.

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“This approval will now give patients more access to a lifesaving drug,” said John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Furthermore, the risk of developing severe malaria emphasizes the importance of taking medications to prevent malaria and using mosquito avoidance measures when traveling to malaria-endemic areas.”

According to the CDC, approximately 2,000 cases of malaria are diagnosed in the U.S. each year, and around 300 of those infected have severe disease. Most people diagnosed with malaria in the United States acquire it during travel to countries with malaria.

The safety and efficacy of IV artesunate was primarily evaluated in a randomized controlled trial in Asia (Trial 1) and a supportive published randomized controlled trial in Africa (Trial 2).

In both trials, the number of patients treated with artesunate who died in the hospital was significantly lower than the number who died in the control group treated with quinine.

In Trial 1, the most common adverse reactions in patients with malaria treated with IV artesunate were acute renal failure requiring dialysis, hemoglobinuria and jaundice. The safety profile in Trial 2 was generally similar to Trial 1.

IV artesunate is the only drug available in the U.S. to treat the disease.

FDA approves med for severe malaria

MasterPharm is voluntarily recalling 1 lot of Finasteride Plus 1.25 mg. capsules to the consumer level.

The capsules undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products, MasterPharm said in a 

. MasterPharm has received 33 reports of increased heart rate, retention of water, dizziness and low blood pressure.

Consumption of undeclared minoxidil would be expected to result in low blood pressure, rapid heartbeat, and salt and water retention causing swelling. Consequently, patients may be at risk for developing heart failure or other heart damage,” MasterPharm said.

Excess fluid between the heart and the sac surrounding the heart has also been reported in association with minoxidil use.

Finasteride Plus is a compounded drug for hair loss and is packaged in orange prescription bottles containing 30 capsules or blue prescription bottles containing 90 capsules.

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The product was distributed nationwide on a patient-specific, prescription basis only, MasterPharm said. The affected Finasteride Plus 1.25 mg. lot number is 02-27-2020:04@11, and it has a Beyond Use Date of August 25, 2020.

Consumers should contact their physician or healthcare provider if they have experienced any problems related to taking the product.

Consumers that have the Finasteride Plus lot that is being recalled should stop using it and return it to MasterPharm via self-addressed packaging, which has been sent to all customers.

Consumers with questions can contact MasterPharm at (866) 630-5600 or 

FDA authorized the first stand-alone, at-home COVID-19 test, plus it warned more companies over COVID-19 claims and fast-tracked a promising vaccine in the top news articles this week. Here is a quick roundup:

emergency use authorization (EUA) to Everlywell, Inc.

 for its Everlywell COVID-19 Test Home Collection Kit, which is authorized to be used by individuals at home who have been screened using an online questionnaire reviewed by a health care provider.

“This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit,” the agency said in a 

“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”  

2. FDA issued warning letters to two companies for selling fraudulent COVID-19 products. It warned 

, which claims its CBD products may help with COVID-19.

“We are getting a lot of questions about whether CBD (Hemp Extract) can help with the Coronavirus (COVID-19),” Noetic said on its web site. “The short answer is YES, it certainly can help. Now, let’s be clear, it is not seen as a cure, but CBD has properties (anti-bacterial, anti-viral, and anti-inflammatory) that can aid with symptoms and help a person stay healthy to fight off illness.”

, which claims that its kratom products are safe and/or effective for the prevention and treatment of COVID-19. “Kratom contains a special compound known as chloroquine or Cq, that research shows is powerfully combative against the coronavirus,” the company said on its web site.

3. FDA granted "fast track" designation to Moderna’s experimental COVID-19 vaccine, Reuters 

. The pharma maker expects to start a late-stage study of the vaccine in early summer and says there is potential for a marketing application approval in 2021, Reuters said.

Moderna announced positive interim clinical data of the vaccine, mRNA-1273, from its Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID).

“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, MD, PhD, chief medical officer at Moderna, in a 

FDA warns CBD companies making medical claims

FDA authorizes first stand-alone, at-home test, plus other top COVID-19 news stories.

U.S. government secures remdesivir supply for COVID-19 patients

In the past week, FDA cleared two novel cancer treatments — one for breast cancer and the other for colorectal cancer.

FDA cleared a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf (Phesgo, Genentech) for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body. Phesgo also treats adult patients with early HER2-positive breast cancer.

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“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an out-patient option for patients to receive trastuzumab and pertuzumab,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a 

“As part of the FDA’s ongoing commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease,” Pazdur added. “At this critical time, we continue to expedite oncology product development. This application was approved about four months ahead of the FDA goal date.”

The FDA’s approval was based on the results of a non-inferiority study in patients with HER2-positive early breast cancer, which demonstrated Phesgo had comparable efficacy and safety as IV pertuzumab and IV trastuzumab, except for administration-related reactions, which were higher with Phesgo due to the subcutaneous route of administration.

Prescribing information for Phesgo includes a boxed warning to advise health care professionals and patients about the risk of potential heart failure, fetal harm and lung toxicity. Health care professionals should use similar monitoring parameters as those used with IV pertuzumab and IV trastuzumab, FDA said.

FDA also approved pembrolizumab (Keytruda, Merck & Co.) for IV injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

“This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy,” FDA said in a 

“Metastatic colorectal cancer is a serious and life-threatening disease with a poor prognosis. Available current therapy with chemotherapy combinations and other biologics are associated with substantial toxicity. Having a non-chemotherapy option available for selected patients is a noteworthy paradigm shift in treatment,” Pazdur said.

FDA’s approval was based on the results of one multicenter, international, open-label, active-controlled, randomized trial that compared Keytruda with chemotherapy treatment in 307 patients with MSI-H or dMMR metastatic colorectal cancer. The study demonstrated a statistically significant improvement in progression-free survival (PFS): median PFS was 16.5 months in the Keytruda group and 8.2 months in the standard of care group, FDA said.

“Longer-term analysis is needed to assess for an effect on survival,” the agency added.

Colorectal cancer drug is the first immunotherapy administered as a first-line treatment and without chemotherapy.

FDA okays novel breast, colorectal cancer treatments

While there are numerous drugs in the pipeline, pharmacy benefit manager OptumRx singled out three top medications expected to have the most impact on payers on patients in the second half of 2020.

Pipeline Insights Report: 3 Drugs to Watch

, OptumRx highlights treatments for breast cancer, spinal muscular atrophy, and Duchenne muscular dystrophy. Here are the top 3 drugs to watch in the second half of this year:

1. Sacituzumab govitecan-hziy (Trodelvy, Immunomedics) was approved in late April to treat patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease.

TNBC is an aggressive breast cancer that accounts for up to 20% of all breast cancer cases.

Trodelvy is a novel antibody-drug conjugate (ADC), which combines both biologically engineered antibodies andtraditional chemotherapy drugs, OptumRx said. It is administered intravenously on a weekly basis over a 21-day cycle.

“Trodelvy is the first ADC targeted therapy for TNBC. There is a high unmet need for treatments in this subtype of breast cancer because of the size of the overall breast cancer population and the aggressive nature of TNBC,” OptumRx said.

In fact, analysts estimate that Trodelvy could reach $1.44 billion in global sales in 2024 global sales, initially as a third-line treatment for late-stage TNBC. The drug is also being evaluated in earlier settings and other cancers.

2. The investigational drug risdiplam (F. Hoffmann-La Roche, PTC Therapeutics, SMA Foundation) would be the first oral therapy to treat spinal muscular atrophy (SMA).

SMA is a rare group of severe neuromuscular disorders that leads to progressive muscle weakness and atrophy. It is the most common genetic cause of infant mortality and one of the most common rare diseases, affecting approximately one in 11,000 babies, OptumRx said.

“There is an unmet need for treatments for SMA, and especially for an all-oral option. There are currently only two FDA- approved drugs for SMA,” OptumRx said.

Nusinersen (Spinraza, Biogen) requires repeated, invasive injections into the cerebrospinal fluid in the spinal cord. The other alternative isonasemnogene abeparvovec (Zolgensma, AveXis) which is a one-time IV-infused gene therapy.

FDA is expected to approve the medication on or before August 24, 2020, according to OptumRx.

“While Spinraza does require invasive spinal injections, it has been widely used in SMA patients since its market entry. Practically speaking, the competitive advantage for risdiplam will rest mainly in its oral route of administration, and perhaps, a lower cost,” OptumRx said.

3. Viltolarsen (Nippon Shinyaku) is in development to treat specific forms of Duchenne muscular dystrophy (DMD). DMD is a rare genetic disorder that affects young boys.

There is a significant unmet need for treatments for DMD since it is associated with substantial sickness and death,” OptumRx said.

If approved, viltolarsen would be the third exon-skipping drug for DMD, and the second specifically for the 8% of patients with a specific mutation.

Golodirsen (Vyondys 53TM, Sarepta Therapeutics) is also approved for the mutation, but there is limited efficacy data and unknown clinical benefit with its use, OptumRx said.

The FDA is expected to make a decision on whether or not to approve viltolarsen in the third quarter of this year.

Read more: 

These are the top 3 drugs recently approved — or soon to be approved by FDA — to watch in 2020.

Top 3 drugs to watch in second half 2020

TG Therapeutics completed the rolling submission of a New Drug Application (NDA) to FDA, requesting accelerated approval of umbralisib to treat certain types of lymphoma.

The investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon will treat patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).

FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

"The completion of this NDA submission marks an important milestone in bringing us one step closer to providing umbralisib as a potential treatment option for patients with relapsed/refractory MZL and FL,” said Michael S. Weiss, TG Therapeutics’ executive chairman and CEO in a 

TG Therapeutics is evaluating umbralisib in the UNITY-NHL trial , a multicenter, open-label Phase 2b trial.

In February 2019, the company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients. The results met the company’s target guidance of 40-50% ORR.

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Investigational treatment will target marginal zone lymphoma (MZL) and follicular lymphoma (FL). 

 (EUA) for chloroquine phosphate and hydroxychloroquine sulfate in hospitalized COVID-19 patients, and warned about a potential drug interaction with the investigational antiviral drug remdesivir and hydroxychloroquine.

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” FDA said in a 

The FDA is also concerned about the “ongoing serious cardiac adverse events and other potential serious side effects,” it said. “The known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The FDA granted the EUA on March 28 based on the science and data available at the time. “Today, in consultation with the FDA, Biomedical Advanced Research and Development Authority (BARDA) sent a letter to the FDA requesting revocation of the EUA based on up to date science and data,” the agency said.

Since the EUA was granted, new data on heart risks associated with the medication have been revealed.

In addition, FDA said that recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. “This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit.”

Meanwhile, FDA also warned healthcare providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir, it said in a 

“The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” FDA said.

In addition, FDA revised the fact sheet for healthcare providers to clarify dosing and administration recommendations and to provide additional safety data and supporting data from clinical trials conducted by both the National Institutes of Health and the drug sponsor, Gilead Sciences.

 was also updated to include additional information about possible allergic reactions and to alert patients to tell their healthcare providers if they are taking chloroquine phosphate or hydroxychloroquine sulfate.


While the safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, preliminary clinical trial results have shown that, on average, patients treated with remdesivir had more rapid time to recovery, FDA said.

The agency revoked its emergency use authorization (EUA) for the drug, while warning about a dangerous interaction with remdesivir.

U.S. government secures remdesivir supply for COVID-19 patients

FDA okays novel breast, colorectal cancer treatments

Top 3 drugs to watch in second half 2020

FDA okays novel breast, colorectal cancer treatments

Top 3 drugs to watch in second half 2020

Pharma maker seeks fast approval of lymphoma treatment

FDA pulls hydroxychloroquine for COVID-19, warns about other drug interaction

New pediatric HIV med available

Major Metformin recalls underway

Remdesivir for COVID-19 in short supply

New antibiotic for hospital-acquired pneumonia available

Drug’s indication expanded to reduce heart attack, stroke risk

Two metformin products recalled, more on the way

FDA approves med for severe malaria

Pharma maker recalls drug over undeclared anti-hypertensive drug

Top 3 COVID-19 stories this week

FDA clears new antigen, saliva tests for COVID-19