FDA issues response letter to Ipsen for Dysport application
PARIS The Food and Drug Administration has issued a complete response letter to French drug maker Ipsen’s approval application for Dysport.
Ipsen submitted its biologics license application for Dysport (botulinum toxin Type A) in 2007 as a treatment for cervical dystonia. In its letter, the FDA did not request any new clinical studies evaluating the efficacy or safety of the drug prior to approval, but did request the finalization of the risk evaluation and mitigation strategy, a safety update report and the draft labeling. Ipsen expects to submit the information in early 2009 and is preparing to launch the drug.
Cervical dystonia, also known as sposmadic torticollis, causes contractions of the neck and shoulder muscles. Dystonia diseases affect at least 300,000 people in the United States, according to the Dystonia Medical Research Foundation.
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.