EAST WINDSOR, N.J. — Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for capecitabine tablets USP, 150 mg, and 500 mg. Aurobindo’s capecitabine tablets USP are an AB-rated generic equivalent to the reference listed drug Xeloda.
Capecitabine tablets are indicated for the treatment of adjuvant colon cancer, matastatic colorectal cancer and metastatic breast cancer.
The product has an estimated market size of $203.5M for the twelve months ending February 2018 according to IMS.
Capecitabine Tablets USP, represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 315 final approvals, including 35 tentative approvals, and 17 approved products from Aurolife. There are 98 additional products on file with U.S. FDA.