A survey of new Rx, new generic, and new OTC products
FDA has approved Discovery Laboratories' Surfaxin (lucinactant) for prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Surfaxin, the first synthetic, peptide-containing surfactant approved for use in neonatal medicine, may become commercially available in the United States later this year. ( http://www.discoverylabs.com/ / 215-488-9300)
FDA has granted approval to Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. to manufacture the first ibandronate tablets 150 mg (generic for Boniva), a once-monthly product to treat or prevent osteoporosis in women after menopause. (Drugs@FDA.com / 888-463-6332)
Prasco will exclusively sell and distribute the authorized generic version of vancomycin hydrochloride capsules, USP, 125 mg and 250 mg, in the United States, as part of an agreement with ViroPharma Inc. Product is indicated for C. difficile-associated diarrhea and is also used to treat enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).
FDA has approved the first escitalopram tablets (generic for Lexapro) to treat both depression and generalized anxiety disorder in adults. Teva/IVAX gained FDA approval to market the generic product in 5-, 10-, and 20-mg strengths. Teva has received a 180-day period of generic drug exclusivity. ( http://www.tevausa.com/ / 888-838-2872)
Teva announced the commercial launch of quetiapine fumarate tablets (generic for AstraZeneca's Seroquel tablets) in 25-, 50-, 100-, 200-, 300-, and 400-mg strengths, for treatment of schizophrenia. ( http://www.tevausa.com/ / 888-838-2872)
Dr Reddy's Laboratories has launched quetiapine fumarate tablets for treatment of schizophrenia, in 25-, 50-, 100-, 200-, 300-, and 400-mg strengths, in the U.S. market, following FDA approval of its ANDA. ( http://www.drreddys.com/ / 91-40-49002900)