Valeant Pharmaceuticals Settles Suit with Kali Laboratories on Diastat Generic Challenge.ALISO VIEJO, 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 it has settled its lawsuit with Kali Laboratories, Inc. for patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. on Diastat[R], the only FDA-approved at-home acute treatment for break-through epileptic seizures. Under the terms of the settlement, the companies reached an agreement in principle that would allow Kali to introduce a generic version of Diastat and Diastat[R] AcuDial[TM] no earlier than September 2010. Other terms of the settlement were not disclosed. In March 2004, Kali submitted an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar with the Food and Drug Administration seeking approval for a generic version of Diastat (a diazepam diazepam /di·az·e·pam/ (di-az´e-pam) a benzodiazepine used as an antianxiety agent, sedative, antipanic agent, antitremor agent, skeletal muscle relaxant, anticonvulsant, and in the management of alcohol withdrawal symptoms. rectal gel). In July 2004, Xcel Pharmaceuticals, Inc., which was acquired by Valeant in March 2005, filed a complaint against Kali for patent infringement. The settlement, which was reached at a conference held last week in the U.S. District Court of New Jersey, requires the companies to finalize the agreement within 60 days. About Valeant Valeant Pharmaceuticals International (NYSE: VRX) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com. Diastat and Diastat AcuDial are trademarks or registered trademarks of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or registered trademarks of their respective owners. |
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