FDA approves Eli Lilly & Co.’s blood-thinning drug
ROCKVILLE, Md. The Food and Drug Administration has approved a new blood-thinning drug to prevent heart attacks in patients who undergo angioplasty surgery.
The agency approved Effient (prasugrel), made by Indianapolis-based Eli Lilly & Co. and Tokyo-based Daiichi Sankyo following a 13,608-patient trial comparing it with Sanofi-Aventis’ and Bristol-Myers Squibb’s Plavix (clopidogrel). During the study, the percentage of people who experienced non-fatal heart attacks following angioplasty was 9.1% among those receiving Plavix and 7% among those receiving Effient.
In angioplasty, surgeons use a small balloon to open an artery that has become clogged with plaque, and a wire mesh called a stent is often inserted into the blood vessel to keep the artery open. However, platelets can collect around the area where the surgery takes place, causing clots that can lead to heart attack, stroke and death.
“Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty proceture,” said John Jenkins, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”
The drug will carry a boxed warning, the highest level of warning that an FDA-approved drug can carry, alerting physicians to the risk of potentially fatal bleeding among patients who take Effient.
Caraco to acquire rights to several drugs from Forest Labs
NEW YORK Generic drug maker Caraco Pharmaceutical Labs will acquire rights to several drugs from Forest Labs under an asset purchase agreement between the two companies.
Caraco announced the agreement Friday as part of a settlement that it and parent company Sun Pharmaceutical Industries had entered with Forest Labs and Danish drug maker H. Lundbeck concerning Caraco’s regulatory approval application for the anxiety and depression drug Lexapro (escitalopram oxalate). Lundbeck had licensed Lexapro to Forest on an exclusive basis in the United States.
Under the agreement, Caraco will take over commercialization and sale of several products from Forest’s Inwood business, paying Forest an advance against royalties. Meanwhile, Forest will reimburse Caraco for a portion of its legal fees and provide licenses to Caraco for certain Lexapro patents as soon as a third-party generic version with Food and Drug Administration approval hits the market.
Watson Pharmaceuticals gets the OK from FDA for new nicotine polacriliex gum
MORRISTOWN, N.J. Watson Pharmaceuticals, a leader in generic and specialty branded pharmaceuticals, announced its subsidiary, Watson Labs, has been granted approval from the Food and Drug Administration to market its nicotine polacrilex gum.
Nicotine polacrilex gum is the generic equivalent of GlaxoSmithKline Consumer Healthcare’s Nicorette Fruit Chill and Cinnamon Surge Coated gums, all of which are available over-the-counter and used to help people stop smoking.
Watson’s nicotine gum will be available as soon as possible in coated fruit and cinnamon flavors.