It is Glenmark’s first injectable approval in the US
Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for bendamustine hydrochloride for injection, 25 mg/vial and 100 mg/vial, the therapeutic equivalent to the reference listed drug product, Treanda for injection, 25 mg/vial and 100 mg/vial, of Cephalon. This is Glenmark’s first injectable granted approval by the US FDA.
Under the terms of the prior settlement agreement, Glenmark will be able to launch its product on November 1, 2019, or earlier under certain circumstances. Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a Paragraph IV certification, therefore, Glenmark may be eligible for 180 days of marketing exclusivity for bendamustine hydrochloride for injection, 25 mg/vial and 100 mg/vial.