Report: Lupin’s generic Fortamet receives FDA nod
NEW DELHI — The Food and Drug Administration has approved a diabetes drug made by Lupin Pharmaceuticals, according to published reports.
The FDA approved Lupin’s metformin hydrochloride extended-release tablets, a generic version of Andrx Labs’ Fortamet.
Fortamet had sales of $83 million in 2010, according to IMS Health.
ODH: 2009 H1N1 vaccines prevented deaths
COLUMBUS, Ohio — An Ohio Department of Health study released Wednesday estimated that Ohio’s H1N1 vaccination efforts prevented 64 deaths, 1,400 hospitalizations and 310,402 cases of influenza during the 2009 H1N1 pandemic. The study also estimated that Ohio’s vaccination efforts saved the state $8.4 million in H1N1-related hospitalization costs.
“Our analysis indicated that Ohio’s collaborative response to the H1N1 pandemic saved lives and kept more than a thousand Ohioans out of the hospital,” ODH director Ted Wymyslo said. “By working together to respond to public health threats like H1N1, with partners in both the public and private sectors, ODH will continue to protect and improve the health of Ohioans.”
To protect Ohio residents from the pandemic, ODH had ordered and shipped 4.1 million doses of vaccine to more than 3,000 providers, including obstetricians, primary care physicians, local health departments and pharmacies from across the state. In addition, ODH released more than $50 million in federal emergency public health preparedness funds — more than 90% of the funds received by Ohio — to support numerous vaccination clinics and prevention efforts at the local level. “Ohio’s local health departments sponsored hundreds of mass vaccination clinics and provided strong local leadership that was integral in our success,” Wymyslo said.
Watson confirms Welchol patent challenge
PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.
The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.
Daiichi Sankyo and Genzyme filed a patent infringement suit against Watson Monday in the U.S. District Court for the District of Delaware, alleging that Watson infringed on two patents covering Welchol. Under the provisions of the Hatch-Waxman Act, the suit puts a stay of FDA approval on the drug until September 2013, or until the companies resolve the matter before the court.
Welchol had sales of $336 million during the 12-month period ended in February 2010, according to IMS Health.