FDA approves Humira to treat ulcerative colitis
October 1st 2012FDA has approved adalimumab (Humira, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.
FDA approves regorafenib tablets for treatment of metastatic colorectal cancer
September 27th 2012FDA approved regorafenib (Stivarga, Bayer HealthCare) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy).
FDA grants priority review to opioid-induced constipation indication for lubiprostone
September 26th 2012FDA has given priority review to an additional indication for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
FDA approves aflibercept injection for macular edema following central retinal vein occlusion
September 24th 2012FDA has approved aflibercept (Eylea, Regeneron) injection for the treatment of macular edema following central retinal vein occlusion (CRVO). The recommended dose for Eylea is 2 mg every 4 weeks (monthly).
FDA issues safety alert on Intestinomicina marketed as treatment for infectious diarrhea
September 18th 2012FDA is warning consumers not to use Intestinomicina (Laboratorios Lopez), a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a healthcare provider.
Azilsartan medoxomil-chlorthalidone fixed combination superior at reducing SBP
September 10th 2012A fixed-dose combination of azilsartan medoxomil plus chlorthalidone (Edarbyclor, Takeda) was statistically superior to azilsartan medoxomil coadministered with hydrochlorothiazide at reducing and maintaining systolic blood pressure, according to the results of a phase 3 study published online August 31 in The American Journal of Medicine.
FDA approves new treatment for a type of late-stage prostate cancer
August 31st 2012FDA approved enzalutamide (Xtandi, Astellas Pharma U.S. Inc. and Medivation) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
FDA warns of possible fatalities from codeine use in some children after surgical procedures
August 15th 2012FDA has issued a Drug Safety Communication concerning three children who died and one child who experienced a nonfatal but life-threatening case of respiratory depression after taking the pain-reliever codeine following tonsillectomy and/or adenoidectomy.
FDA grants accelerated approval for treatment of rare type of leukemia
August 10th 2012FDA has approved vincristine sulfate liposome injection for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) who have had at least 2 relapses or whose disease has progressed following 2 or more anti-leukemia therapies
FDA approves aclidinium bromide inhalation powder to treat COPD
July 24th 2012FDA has approved aclidinium bromide inhalation powder (Tudorza Pressair, Forest) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Study: Zithromax associated with cardiovascular deaths; FDA reviewing
May 18th 2012FDA has notified healthcare professionals that it is aware of a study published in the New England Journal of Medicine reporting a small increase in cardiovascular deaths and in the risk of death from any cause in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug.
Hospira recalls one lot of hydromorphone injection
May 14th 2012Hospira is voluntarily recalling one lot of hydromorphone injection, USP, 1 mg/mL (C-II), 1-mL fill in 2.5-mL Carpuject, NDC 0409-1283-31, after complaints that a single Carpuject contained more than the 1-mL labeled fill volume, according to a press release posted on the FDA website.
FDA hears from stakeholders about biosimilar product development
May 14th 2012Pharmacists need additional guidance on the handling of biosimilar products in the pharmacy when these products become more widely available following the approval of the biosimilar pathway, said Marcie Bough, senior director of government affairs, APhA, speaking at an FDA hearing last week.