Allergan files ANDA for generic version of Abraxane

Allergan recently announced that it has submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for the approval of market Paclitaxel Protein-Bound Particles for Injectable Suspension, 100 mg/vial.

Allergan’s proposed product is the generic version of Celgene’s Abraxane. Abranxane is used to treat metastatic breast cancer when combination chemotherapy fails or when patients relapse within six months of adjuvant chemotherapy; the treatment of non-small cell lung cancer (NSCLC) that is advanced locally or metastatic as a first-line treatment, when combined with carboplatin, for patients who are not candidates for radiation therapy or curative surgery; and the first-line treatment of metastatic adenocarcinoma in the pancreas when combined with gemcitabine.

Based on data from research, Allergan believes that it is the first company to file an ANDA for a generic brand of Abraxane. If the ANDA is approved Allergan could possibly have a 180-day generic market exclusive.

Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patientsl.