On March 7, 2016 Celgene Corporation (NASDAQ: CELG, CELGZ) reported that it has received a Paragraph IV Notice Letter advising that Actavis LLC 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 ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin bound) 100 mg/vial in the United States (Press release, Celgene, MAR 7, 2016, View Source [SID:1234509390]). Schedule your 30 min Free 1stOncology Demo! The Notice Letter contains Paragraph IV certifications against certain patents relating to ABRAXANE. Celgene is assessing the notice. Celgene intends to vigorously defend its extensive intellectual property rights relating to ABRAXANE.
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About ABRAXANE
In the U.S., ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also indicated for the first-line treatment of metastatic adenocarcinoma of the pancreas in combination with gemcitabine.