GlaxoSmithKline announced today the FDA approval of Avandamet (rosiglitazone maleate and metformin HCl) for use as initial treatment of type 2 diabetes as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy --indicated for use in patients who were uncontrolled on metformin monotherapy.
Merck announced today that the FDA has approved Emend (aprepitant) for the prevention of postoperative nausea and vomiting, one of the most common side effects associated with surgical procedures.
The FDA has approved Genentech’s Lucentis (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD) after a six-month priority review.
Celgene Corporation received FDA approval for its supplemental new drug application (sNDA) for Revlimid use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. Revlimid is also approved for use in the treatment of patients with transfusion-dependent anemia.
Wyeth has been issued an approvable letter for its oral contraceptive Lybrel (90 microgram levonorgestrel/20 microgram ethinyl estradiol tablets). In response to the approvable letter, Wyeth will submit additional stability data regarding the Lybrel manufacturing method and additional analyses of submitted clinical data.
The FDA granted Novartis’ Alzheimer’s disease drug Exelon an expanded indication for the treatment of dementia in Parkinson’s disease patients.
Sanofi-Aventis said it would update prescribing information for its antibiotic Ketek (telithromycin) following an FDA safety assessment advising doctors and patients to be aware of rare but serious health risks associated with use of the drug. The revised prescribing information contains a bolded warning and additional information telling patients to discontinue Ketek use if hepatitis-like symptoms develop and also recommends that Ketek only be used in patients with myasthenia gravis, a neuromuscular disorder, if no other treatment option is available. Ketek is often prescribed to treat upper respiratory tract diseases such as bronchitis but has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug.