Innopharma gets FDA nod for epilepsy generic
PISCATAWAY, N.J. — The Food and Drug Administration has approved a generic drug for epilepsy.
Innopharma announced the FDA approval of levetiracetam injection. The drug is a generic version of UCB’s Keppra.
Innopharma has a licensing agreement with X-GEN Pharmaceuticals for marketing and distribution of the drug.
More research supports omega-3, heart health connection
DENVER — Omega-3 polyunsaturated fats, or PUFAs, found in seafood may reduce arterial stiffness and improve heart function in chronic heart failure, according to new research released Wednesday.
"The consumption of nearly 1 g of omega-3s per day may improve the elasticity of the arteries, especially in individuals at high risk of heart disease," PUFA Newsletter editor Joyce Nettleton said. "Measurement of arterial stiffness is a powerful predictor of future heart events and the risk of dementia and death."
Other studies showed that a high dose (4 g/day) of omega-3s is linked to improved heart function in people with severe chronic heart failure. Further, eating baked or broiled fish regularly may substantially lower the chance of heart failure in women after menopause. Choosing fattier types of fish, such as salmon, mackerel, sardines and tuna, may be even more favorable, according to Nettleton.
DHA, found in fattier fish, also proved beneficial when given to animals up to five hours after a stroke. "Whether similar results would be obtained in humans is the pot-of-gold question waiting for clinical evaluation," Nettleton noted.
These findings and more are summarized in the August 2011 PUFA Newsletter and Fats of Life newsletters for health professionals and consumers, respectively.
To read the complimentary PUFA Newsletter and Fats of Life newsletters, go to Fatsoflife.com.
Watson gets tentative approval for Crestor generic
MORRISTOWN, N.J. — The Food and Drug Administration has granted tentative approval to a generic cholesterol drug made by Watson Pharmaceuticals, the company said Wednesday.
Watson announced the tentative approval of Watson’s rosuvastatin zinc tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of AstraZeneca’s Crestor. Tentative approval means that the drug meets the FDA’s conditions for approval, but the agency can’t allow it to be marketed because patents covering the branded version have yet to expire.
Watson is aiming to be the first company to market a generic version of Crestor, and its regulatory approval application prompted AstraZeneca to file a patent infringement suit against it in October. AstraZeneca’s suit prevents Watson from commercializing the drug and places a stay of final FDA approval on it until April 2013 or until the companies reach an agreement in court.
Crestor is one of the top-selling drugs in the country, with 2010 sales of $3.8 billion, according to IMS Health.