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FDA Approves New Formulation of Coagulation Therapy
The U.S. Food and Drug Administration today approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.
"Approval of this product for room temperature storage creates greater flexibility in disease management for both patients and physicians," said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. "As with all FDA-approved products, the agency will monitor NovoSeven RT throughout its life cycle."
NovoSeven RT—the new formulation of NovoSeven Coagulation Factor VIIa (Recombinant)—contains sucrose and L-Methionine, which allow for storage at room temperature. This is helpful for health-care facilities with limited refrigerated space. The original formula could be stored for three years at temperatures between 36 and 46 degrees Fahrenheit.
FDA Approves First Generic Ropinirole
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
Ropinirole hydrochloride tablets have been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram.
"This generic drug approval is an example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.
The following companies have received approval to market ropinirole hydrochloride tablets: Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc.
The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease. The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.
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