February 10, 2012
By:Formulary staff
FDA has approved mitomycin (Mitosol, Mobius Therapeutics) for use in glaucoma surgery.
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February 8, 2012
By:From staff reports
FDA has approved lisdexamfetamine dimesylate (Vyvanse, Shire) capsules, (CII) as a maintenance treatment for adults with ADHD. Vyvanse was already approved as a treatment for ADHD in patients aged 6 to 17 years.
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February 7, 2012
By:Formulary staff
FDA has granted priority review to crofelemer 125-mg tablets (Salix Pharmaceuticals) for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART).
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February 6, 2012
By:Formulary staff
Following a priority review, FDA has approved an update to imatinib mesylate (Gleevec, Novartis) tablets? label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.
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February 6, 2012
By:Formulary staff
FDA has approved (linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, which combine the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar.
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February 3, 2012
By:Formulary staff
FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.
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February 2, 2012
By:From staff reports
FDA has approved exenatide extended-release for injectable suspension (Bydureon, Amylin and Alkermes) ? the first once-weekly treatment for type 2 diabetes.
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February 1, 2012
By:From staff reports
FDA approved ivacaftor (Kalydeco, Vertex Pharmaceuticals) for the treatment of a rare form of cystic fibrosis in patients aged 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator gene.
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January 4, 2012
By:From staff reports
FDA has approved Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (Prevnar 13, Pfizer) as a single dose for use in adults aged 50 years and older.
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