FDA approves Osmotica’s generic Effexor
WASHINGTON The Food and Drug Administration has given final approval to Osmotica Pharmaceutical for a treatment for major depressive disorder and social anxiety disorder.
Osmotica received approval for 37.5 mg, 75 mg, 150 mg and 225 mg extended-release tablets of the drug venlafaxine hydrochloride. The drug is bioequivalent to Wyeth’s Effexor XR when administered under fed conditions. Osmotica will launch the product line for the two FDA-approved indications soon.
Osmotica is part of the multinational Osmotica Group, a group of companies with primary operations in the U.S. and Argentina that specializes in neurological drugs and technologies.
FDA approves Teva’s generic Sarafem Pulvules
JERUSALEM The Food and Drug Administration has granted final to Teva Pharmaceuticals to market a drug for treating premenstrual dysphoric disorder.
The drug, fluoxetine, is a generic version of Eli Lilly’s drug Sarafem Pulvules. The FDA granted approval for Teva’s application for 10 mg and 20 mg capsules of the drug Wednesday. The FDA granted a first-to-file 180-day marketing exclusivity to Teva. The drug will ship immediately.
Teva, headquartered in Israel, is a manufacturer of generic drugs and one of the 20 largest pharmaceutical companies in the world. Teva North America operates in California, Missouri, Florida, New York, New Jersey and Pennsylvania.
FDA issues approvable letter for Wyeth osteoporosis drug
WASHINGTON Wyeth Pharmaceuticals received an approvable letter from the Food and Drug Administration for a drug to treat postmenopausal osteoporosis, the company announced Friday.
The FDA requested further analysis concerning stroke and venous thrombosis for the drug, known as bazedoxifene. The FDA made similar requests when Wyeth Pharmaceuticals filed a new drug application in December 2007. The company expects to respond to the new letter by the end of this year.
Wyeth Pharmaceuticals is a division of Wyeth, a global company specializing in pharmaceuticals, consumer healthcare products and animal healthcare products.