FDA approves first naloxone treatment to be given by caregivers to reverse opioid overdose
April 10th 2014FDA has approved naloxone hydrochloride injection (Evzio; Kaléo, formerly Intelliject) for emergency treatment when opioid overdose is known or suspected because of respiratory and/or central nervous system depression.
Xartemis XR receives FDA approval: May reduce opioid abuse
March 28th 2014Oxycodone hydrochloride and acetaminophen (Xartemis XR, Mallinckrodt) Extended-Release Tablets (CII) were approved for the management of acute pain requiring opioid treatment. Xartemis XR has been specifically formulated to reduce abuse, according to the drug’s manufacturer.
Apixaban now approved to reduce risk of blood clots after hip, knee surgery
March 22nd 2014FDA has approved apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip- or knee-replacement surgery.
Once-daily topiramate XR approved for refractory seizures
March 18th 2014FDA approved once-daily topiramate (Qudexy XR, Upsher-Smith Laboratories) extended-release capsules for initial monotherapy in patients aged 10 years and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures.
OA treatment for knee pain approved by FDA
February 28th 2014FDA has approved hyaluronic acid (HA) injection (Monovisc, Anika Therapeutics), a single-injection supplement to synovial fluid of the osteoarthritic joint, for the treatment of pain and the improvement of joint mobility in patients with osteoarthritis (OA) of the knee.
FDA approves Myalept for rare metabolic disease
February 25th 2014FDA approved metreleptin for injection (Myalept, Amylin Pharmaceuticals) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.
FDA approves single-agent treatment for chronic lymphocytic leukemia
February 12th 2014FDA expanded the approved use of ibrutinib (Imbruvica, Pharmacyclics and Janssen Biotech) as a single-agent, oral kinase inhibitor for chronic lymphocytic leukemia (CLL) patients who have received at least 1 previous therapy.
First drug of new class available for PAH
February 11th 2014Riociguat (Adempas, Bayer Healthcare Pharmaceuticals Inc.) was approved by FDA on October 8, 2013 for two patient groups. It is intended for patients with pulmonary arterial hypertension (PAH) World Health Organization (WHO) group 1 to improve exercise capacity, improve WHO functional class, and delay clinical worsening. It is also approved for patients with pulmonary hypertension (PH) WHO Group IV who have inoperable or persistent/recurrent postoperative chronic thromboembolic pulmonary hypertension (CTEPH), with the intent of improving exercise capacity and WHO functional class.
FDA approves higher dose, less-frequent dosing regimen for Copaxone
January 30th 2014FDA approved a 40 mg/mL dose of glatiramer acetate injection (Copaxone, Teva Pharmaceutical Industries Ltd.) to be used three times a week for patients with relapsing forms of multiple sclerosis (MS). This new higher-dose formulation will allow for a less-frequent dosing regimen.
Farxiga rebounds, approved to treat type 2 diabetes
January 9th 2014FDA has approved dapagliflozin tablets (Farxiga, Bristol-Myers Squibb and AstraZeneca) to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. This marks a rebound for the drug, which FDA rejected last year, citing concerns raised by studies linking the drug to bladder cancer and liver toxicity.
FDA approves first once-daily dual bronchodilator for COPD
December 20th 2013FDA approved umeclidinium and vilanterol inhalation powder (Anoro Ellipta, GlaxoSmithKline and Theravance) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
FDA approves Kcentra for warfarin reversal in emergency surgery patients
December 18th 2013FDA expanded the indication for Prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure.
FDA approves the first generic versions of depression drug Cymbalta
December 12th 2013FDA announced that it had given approval to several pharmaceutical companies to market duloxetine delayed-release capsules (Cymbalta, Eli Lilly), for the treatment of depression and other conditions. in various strengths. Companies named were Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd.
Sovaldi approved to treat chronic hepatitis C
December 9th 2013FDA has approved sofosbuvir (Sovaldi, Gilead) to treat chronic hepatitis C virus (HCV) infection. According to FDA, Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
FDA approves simeprevir for hepatitis C virus
November 25th 2013FDA has simeprevir (Olysio, Janssen Therapeutics, Division of Janssen Products, LP) for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.