GSK, Valeant respond to CRL for ezogabine
LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration’s complete response letter for the companies’ investigational anti-epileptic drug.
GSK and Valeant said that their new drug application for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures, was not approved by the FDA, and said they received the CRL on Nov. 30, 2010. Last August, the FDA announced it pushed back its review of ezogabine after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.
The FDA issues a CRL when it has finished reviewing the application for a drug but issues remain that preclude final approval.
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.