Valeant Pharmaceuticals Receives Approvable Letter from FDA Regarding Zelapar.COSTA MESA, Calif. -- Valeant Pharmaceuticals International Valeant Pharmaceuticals International is a pharmaceutical company with activities spanning the drug discovery pipeline from target identification through clinical trials and commercialization. (NYSE NYSE See: New York Stock Exchange :VRX VRX Virtual Resources Executive VRX Voice Receive Mode ) today announced that the company received an approvable letter from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for Zelapar(TM) (selegiline hydrochloride se·leg·i·line hydrochloride n. A drug that is an irreversible inhibitor of a specific type of monoamine oxidase, used in conjunction with levodopa and carbidopa to treat patients with Parkinson's disease. ). The approvable letter requests additional clarification on specific issues previously addressed by Valeant. Valeant plans to meet with the FDA, promptly as they have requested, to discuss and resolve these matters. About Valeant Pharmaceuticals Valeant Pharmaceuticals International (NYSE:VRX) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets products primarily in the areas of neurology, infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. and dermatology. More information about Valeant can be found at www.valeant.com. Zelapar is a trademark of Valeant Pharmaceuticals International or its related companies. FORWARD-LOOKING STATEMENTS: This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant Pharmaceuticals, including the outcome of the FDA's review of clinical trial data. These statements are based upon the current expectations and beliefs of Valeant Pharmaceuticals' management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond Valeant Pharmaceuticals' control, clinical results that indicate continuing clinical and commercial pursuit of Zelapar is advisable, and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission. |
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