Barr Laboratories, Inc., a Barr Pharmaceuticals, Inc. subsidiary is challenging the patents on Aventis Pharmaceuticals, Inc.’s NASACORT® AQ (Triamcinolone Acetonide) Nasal Spray. NASACORT AQ (Triamcinolone Acetonide) Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older and Barr believes that it is first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for NASACORT AQ. Together with Perrigo Company, Barr developed its Triamcinolone Acetonide Nasal Spray and will share costs and potential benefits with Perrigo under the terms of an agreement.
Barr filed its ANDA for Triamcinolone Acetonide Nasal Spray containing a paragraph IV certification with the U.S. Food & Drug Administration (FDA) in December 2005 and received notification of the application's acceptance for filing in March 2006.
Barr immediately notified Aventis Pharmaceuticals after receiving the notice from FDA. Aventis Pharmaceuticals is the NDA holder and patent owner of the product who later filed suit in the U.S. District Court of Delaware to prevent Barr from proceeding with the commercialization of its product. Such an action by Aventis formally initiates the patent challenge process under the Hatch-Waxman Act.
Source: Barr Labs Press Release
The lab is maked slightly different from the normal lab. The appearence will shows them. The lab must neat always is the main thing. There is so good secure to produce medicine and the main one is nasal spray. It is fabulous.
I have no words to explain this lab.
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Tom
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Posted by: tom2000 | December 22, 2008 6:56 AM | Permalink to Comment