Zerit generic gets FDA approval
PITTSBURGH The Food and Drug Administration has approved a generic version of Bristol-Myers Squibb’s Zerit by Mylan’s Indian subsidiary, Mylan announced Tuesday.
The FDA approved Matrix Labs? stavudine capsules USP in 15 mg, 20 mg, 30 mg and 40 mg strengths. The drug is an antiretroviral used to treat HIV infection in combination with other antiretroviral drugs. The branded version of the drug had sales of about $54 million in the 12 months ending Sept. 30, according to IMS Health data.
Mylan owns a 71.5% stake in Matrix.
KV subsidiary hydromorphone hydrochloride tablets
ROCKVILLE, Md. A subsidiary of KV Pharmaceutical has recalled a lot of hydromorphone hydrochloride 2 mg tablets due to the possibility of oversized tablets, the Food and Drug Administration announced Tuesday.
Ethex Corporation and the FDA have notified healthcare professionals of the recall. The FDA that the oversized pills may lead to improper dosage, thus increasing the risk of adverse side affects associated with the drug, including difficulty breathing, low blood pressure and sedation.
The recalled tablets are round and blue, with a script “E” on one side and a “2” on the other. The recalled lot number is 90219, with an expiration date of March 2010 and the NDC number 58177-0620-04.
The tablets are a generic version of Purdue Pharma?s Dilaudid and used to treat severe pain.
Eli Lilly signs $497 million deal for dirucotide
NEW YORK Eli Lilly & Co. may get some relief from its drying pool of patent-protected drugs.
The Indianapolis drug maker has signed an agreement worth $497 million with biotech firm BioMS Medical Corp. for the drug dirucotide, a treatment for multiple sclerosis.
Expiring patents on Lilly drugs place nearly $10 billion of the company’s sales under threat.