FDA tentatively approves Seroquel generic
JERUSALEM The Food and Drug Administration has given tentative approval to a generic version of AstraZeneca’s antipsychotic Seroquel.
Teva announced last Tuesday that the FDA had granted the tentative approval for generic Seroquel (quetiapine fumarate) in 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg strengths.
The branded version of the drug had sales of about $3.8 billion in the United States for the 12 months ending Sept. 30, according to IMS Health data.
Teva expects to receive final approval after resolving patent litigation with AstraZeneca.
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.