On April 3, 2017 Celgene Corporation (NASDAQ:CELG) reported that it has received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking authorization from the FDA to manufacture and market a generic version of POMALYST (pomalidomide) 1 mg, 2 mg, 3 mg and 4 mg in the United States (Press release, Celgene, APR 3, 2017, View Source [SID1234518427]). Schedule your 30 min Free 1stOncology Demo! The Notice Letter contains Paragraph IV certifications against certain patents related to POMALYST. Celgene is assessing the notice. Celgene intends to vigorously defend its extensive intellectual property rights related to POMALYST.
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About POMALYST
In the U.S., POMALYST (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.