More generics receive clearance for marketing by the FDA

Chain Drug Review, Dec 8, 2008

WASHINGTON -- The Actavis Group has received Food and Drug Administration approval to market bupropion hydrochloride extended-release tablets, 150 mg. The company also markets a 300-mg version of the product, indicated for the treatment of major depressive disorder.

Annual sales of brand and generic versions of the drug in the United States are estimated at $1.48 billion.

"Bupropion XL 150 mg, together with 300 mg [which Actavis launched in August], offers significant value to our customers and patients," points out Doug Boothe, chief executive officer of Actavis' operations in this country. "This approval also underscores Actavis' emphasis and capability in bringing complex controlled-release products to the marketplace."

The United States serves as the largest single market for Actavis.

Also receiving regulatory approval for bupropion hydrochloride extended-release tablets in the 150-mg strength was California-based Watson Pharmaceuticals Inc.

The FDA has also cleared abbreviated new drug applications (ANDAs) for a number of other companies.

Mylan Pharmaceuticals Inc., for example, received regulatory approval for fluoxetine capsules USP in 10-and 20-mg strengths. Fluoxetine capsules are indicated for the treatment of premenstrual dysphoric disorder (PMDD).

Mylan's product is the equivalent to Eli Lilly and Co.'s Sarafem Pulvules capsules, which have annual U.S. sales of about $19.2 million.

Mylan officials point out that the Pittsburgh-based company has 112 ANDAs pending regulatory approval and that 23 of those products hold the potential of being first-to-file opportunities.

Sandoz, a division of Novartis AG, also received approval for generic Sarafem in those strengths. The company is marketing the product in unit-of-use blister packages of 28 capsules.

The company notes that as many as 10% of menstruating women suffer from PMDD.

Sandoz has also announced the introduction of eplerenone tablets, a generic equivalent of Inspra. Sandoz' product is available in 25- and 50-mg strengths. Eplerenone tablets are used to treat high blood pressure as well as heart failure.

Teva Health Systems has debuted rocuronium bromide injection, AP-rated to Organon USA Inc.'s Zemuron. Rocuronium bromide injection is available in two strengths: 10 mg/mL-50 mg and 10 mg/mL-100 mg, both in multiple-dose glass vials.

"Teva offers a broad range of quality health systems generics from a single source," says director of marketing Jennifer Guzman. "We are pleased to announce this latest addition to our growing line of products."

Teva Health Systems is a unit of Teva Pharmaceuticals Industries Ltd, recognized for having one of the leading ANDA approval records in the genetic drug industry.