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.

Barr Pharmaceuticals Inc. has received FDA approval for pramipexole dihydrochloride in 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg strengths. This drug is the generic version of Boehringer Ingelheim Pharmaceuticals Inc.’s Mirapex tablets, used for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. Barr is currently challenging a patent protecting Mirapex and has agreed not to launch its generic Mirapex until 90 days following the conclusion of the presentation of evidence in the district court trial, a favorable judgment is entered by the district court or July 14, whichever comes earlier.

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.