New Rx, OTC, and generics (December 2010)

Key Points

New drugs

FDA has approved Warner Chilcott's bisphosphonate Atelvia (risedronate sodium delayed-release tablets) for the treatment of postmenopausal osteoporosis. The product is a delayed-release formulation of Actonel, which is approved to prevent and treat postmenopausal osteoporosis and glucocorticoid-induced osteoporosis (in men and women), to increase bone mass in men with osteoporosis, and to treat Paget's disease of the bone. ( http://www.wcrx.com/800-521-8813)

Bristol-Myers Squibb's Baraclude (entecavir tablets), a nucleoside analog, is approved for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease. Baraclude is already indicated for the treatment of CHB infection in adults with evidence of active viral replication and evidence of either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ( http://www.baraclude.com/800-321-1335)

Fera has launched a preservative-free formulation of Garamycin (gentamicin sulfate ophthalmic ointment), indicated for the treatment of susceptible ocular bacterial infections, including conjunctivis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis. ( http://www.ferapharma.com/414-434-6604)