Fougera receives FDA approval for generic Aldara
MELVILLE, N.Y. The Food and Drug Administration has given E. Fougera & Co. approval for the first generic version of a topical drug for treating skin diseases, Fougera announced.
The Melville, N.Y.-based generic drug maker got the agency’s nod for imiquimod cream in the 5% strength, a generic version of Graceway Pharmaceuticals’ Aldara. The drug works by activating the body’s immune system to fight actinic keratosis, genital warts and superficial basal cell carcinoma.
Aldara had sales of $360 million in 2009, according to industry data.
As the first company to win approval for a generic version of the drug, Fougera will get six months of market exclusivity in which to compete directly with the branded version, under the terms of the Hatch-Waxman Act of 1984.
Kerr Drug honored for MTM services
RALEIGH, N.C. Thousands of patient interventions by Kerr Drug pharmacists have earned the chain recognition from a leading pharmaceutical health provider as the nation’s top provider of pharmacy-based medication therapy management.
It’s the third year in a row Kerr has won the honor, bestowed by Outcomes Pharmaceutical Health Care, a national MTM provider network. In bestowing the award, Outcomes noted that Kerr pharmacists served nearly 10,000 MTM-eligible patients in 2008, saving more than $2 million in estimated costs.
“Over the past year, Kerr Drug has remained a front-runner in the provision of MTM services and has clearly demonstrated the value pharmacists deliver to the health care system,” said Outcomes VP Brand Newland.
Outcomes also named the Kerr store in Moncks Corner, S.C., as the top individual pharmacy for 2008 in its eighth region, an operating area that represents Georgia and South Carolina.
New drug application review for Exenatide extended
INDIANAPOLIS A diabetes drug developed by Amylin, Eli Lilly and Alkermes will be reviewed by the Food and Drug Administration March 12.
The revised action date of Exenatide once weekly is the result of the FDA’s decision to allow five additional days for its review of pending regulatory applications following the agency’s recent five-day weather-related closure.
Exenatide once weekly is an investigational, extended-release medication for Type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The NDA for exenatide once weekly was submitted in May 2009 and accepted by the FDA in July 2009.