FDA grants application approvals for three generics to Glenmark
WASHINGTON The Food and Drug Administration granted application approvals to Glenmark Generics for three new generic drugs.
The drugs, including an ointment and a cream, each containing 0.1 percent mometasone furoate, and metformin hydrochloride tablets in 500 mg, 850 mg and 1,000 mg doses, will soon hit the U.S. market.
Mometasone furoate, marketed under the brand Elocon by Kenilworth, N.J.-based Schering-Plough, is a corticosteroid of medium potency used to treat dermatosis. Schering-Plough had total sales of $12.7 billion in 2007. Metformin hydrochloride, marketed by New York-based Bristol-Myers Squibb as Glucophage, is an oral antihyperglycemic drug used to manage Type 2 diabetes. Bristol-Myers Squibb had sales of $19.3 billion in 2007.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals, based in Mumbai, India.
Bystolic fulfills pharmacists’ desire for a new beta-blocker
NEW YORK Forest Laboratories and Mylan’s new, once-daily hypertension drug Bystolic now is available in pharmacies nationwide.
A recent survey showed that out of 20,000 retail pharmacists, 78 percent felt there was a need for a beta-blocker with an improved tolerability profile.
More than 2,000 people received Bystolic (nebivolol) during clinical trials. The drug’s efficacy was similar to that of other approved beta-blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.
Hypertension affects about 72 million adults in America.
Tenn. pharmacy school receives $600,000 grant
NASHVILLE, Tenn. Lipscomb University has received a $600,000 grant from The Memorial Foundation to support the school’s new $10.1 million pharmacy school, which will receive its first class in August, according to published reports. The Lipscomb College of Pharmacy has accepted 75 students in its first class.
The money will be used to build three patient support laboratories where students will learn to compound and prepare drugs, carry out experiments and examine and assess patients.
The school will be located in the Burton Health Sciences Center. In honor of the foundation’s grant the labs will be named The Memorial Foundation Pharmacy Practice Center.
“We believe it is a good investment for the community and for those students who want to prepare for a career in pharmacy,” said J.D. Elliott, president of The Memorial Foundation.