FDA advisory panel to discuss approval of new blood-thinning drug from Eli Lilly
NEW YORK A Food and Drug Administration advisory panel may recommend approval of prasugrel, a blood-thinning drug from Eli Lilly & Co.
The advisory panel will meet next Tuesday to discuss whether the FDA should approve the drug, which Indianapolis-based Lilly developed with Japanese drug maker Daiichi Sankyo.
Designed to prevent heart attacks, the drug would be marketed under the brand name Effient. It would compete with the Bristol-Myers Squibb and Sanofi-Aventis drug Plavix (clopidogrel bisulfate).
FDA approves generic version of Depakote
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of Abbott’s Depakote, FDA records show.
The agency approved Dr. Reddy’s Labs divalproex sodium delayed-release capsules in the 125 mg strength. The capsules are used to treat epilepsy, bipolar disorder and migraine headaches.
The branded version of the drug had sales of $1.5 billion in 2007, according to Abbott financial records.
FDA approves Mylan’s generic epilepsy drug
PITTSBURGH The Food and Drug Administration has approved Mylan’s generic version of GlaxoSmithKline’s epilepsy drug Lamictal, Mylan announced Wednesday.
The drug, known generically as lamotrigine, is also used to treat bipolar disorder. Mylan will sell the drug in the 25 mg, 100 mg, 150 mg and 200 mg strengths. The FDA also approved Genpharm?s application for a chewable generic version of Lamictal.
The branded version of the drug had sales of about $91 million in the year ending Sept. 30, according to IMS Health.