Celgene notified of Teva generic application
Celgene Corporation (NASDAQ: CELG) has received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. (NASDAQ: TEVA) 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.
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®.