Innovator Pronova BioPharma announced (in a press release Here) that Pronova and its U.S. marketing partner GlaxoSmithKline have received a Paragraph IV Notice on March 17, 2009 from Par advising that Par has submitted an Abbreviated New Drug Application (ANDA) to the USFDA for approval to market a generic version of Omega-3-acid Ethyl Esters 1 g capsules (Lovaza).
Pa's notice letter states that its ANDA contains a Paragraph IV Certification alleging that the US5502077 (Expiry: Mar 26, 2013) and US5656667 (Expiry: Aug 27, 2018) patents are not valid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of Par's product.
Pa's notice letter states that its ANDA contains a Paragraph IV Certification alleging that the US5502077 (Expiry: Mar 26, 2013) and US5656667 (Expiry: Aug 27, 2018) patents are not valid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of Par's product.
Also, Teva has filed ANDA with Paragraph IV certification against this product as reported earlier by IP Pharma Doc Here
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