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Lotus Pharmaceutical Company Inc. Filed Its Abbreviated New Drug Application (ANDA) Containing a Paragraph IV Certification for a Generic Version of Xenical(R) with the U.S. Food & Drug Administration (FDA)
By: PR Newswire
Dec. 11, 2012 06:46 AM
TAIPEI, Taiwan, Dec. 11, 2012 /PRNewswire/ -- Lotus Pharmaceutical Company Inc. has confirmed its submission of Abbreviated New Drug Application ("ANDA") for Orlistat capsules, a generic version of Xenical®, to the US Food and Drug Administration (FDA). Lotus has informed Hoffman La Roche on the Paragraph IV certification within 20 days of its submission at the end of September, notifying them of the application and providing documents on non-infringement. So far, Roche has not filed a patent lawsuit within 45 days in accordance with current regulations.
Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet.
About Lotus Pharmaceutical Company Inc.
Lotus Pharmaceutical Company Inc. is a Taiwan based emerging specialty pharmaceutical company dedicated to the development and manufacturing of oral solid dosage forms of generics including hormone, cytotoxic and soft-gel capsule products. It has filed several ANDA applications since 2008. Lotus is headquartered in Nantou, Taiwan.
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SOURCE Lotus Pharmaceutical Company Inc.
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