Impax Laboratories, Inc. (NASDAQ:IPXL) confirms that it has provided notice to the patent and New Drug Application (NDA) holders that it has submitted an Abbreviated New Drug Application (ANDA) for doxycyline hyclate delayed-release tablets 150 mg, generic of Doryx®, to the U.S. Food and Drug Administration (FDA). Impax’s ANDA, contains a Paragraph IV certification stating that the Company believes its product does not infringe US Patent No. 6,958,161, or that the patent is invalid or unenforceable.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialize the products.
Doryx® is a tetracycline-class antibacterial indicated for rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, including inhalational anthrax (post-exposure), alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria. According to Wolters Kluwer Health, U.S. sales of Doryx® 150 mg were approximately $29 million in the 12 months ended January 2009.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities.
Doryx rebate
Doryx rebate
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