The FDA has concluded that Teva Pharmaceutical’s bupropion XL 300 mg, a generic version of Wellbutrin XL, is a safe and effective treatment for patients suffering from depression. Questions about the safety and efficacy of Teva’s bupropion XL arose after the agency received 85 postmarketing reports of patients experiencing side effects after switching from GlaxoSmithKline’s Wellbutrin (bupropion HCl) to the generic version.

Teva Pharmaceutical Industries has received FDA approval for the Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer’s chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection. Camptosar’s patent expired last month and the drug had annual sales of about $556 million in the U.S. in the twelve months ended December 31, 2007. The other companies that have received approval to launch the generic version of Pfizer’s chemotherapy agent are Actavis and APP Pharmaceuticals.

Merck & Co.’s Fosamax (alendronate sodium) now has competition. Teva Pharmaceutical Industries Ltd. has received FDA approval for a generic version of Fosamax for osteoporosis treatment. The generic has been approved in doses of 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. The company has marketing exclusivity for 180 days and plans to commence shipment of the drug immediately.

Teva Pharmaceutical Industries Ltd. has received tentative FDA approval for its ANDA (abbreviated new drug application) to market a gastric-acid pump inhibitor. Teva is currently in patent dispute litigation over the product, which is a generic form of TAP Pharmaceutical’s drug Prevacid (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg.