Glenmark Pharma gets FDA approval for bendamustine HCl and two oral contraceptives

FDA has approved bendamustine hydrochloride (Glenmark Pharmaceuticals) for injection, 25 mg/vial and 100 mg/vial. It is the therapeutic equivalent to bendamustine hydrochloride (Treanada—Cephalon) for injection, 25 mg/vial and 100 mg/vial. Glenmark will be able to launch the drug on Nov. 1, 2019, or earlier under certain circumstances.

FDA has approved bendamustine hydrochloride (Glenmark Pharmaceuticals) for injection, 25 mg/vial and 100 mg/vial. It is the therapeutic equivalent to bendamustine hydrochloride (Treanada—Cephalon) for injection, 25 mg/vial and 100 mg/vial. Glenmark will be able to launch the drug on Nov. 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, and may be eligible for 180 days of marketing exclusivity for bendamustine hydrochloride for injection, 25 mg/vial and 100 mg/vial. FDA also approved drospirenone and ethinyl estradiol tablets USP, 3 mg/0.03 mg (Glenmark Pharmaceuticals), the generic version of Bayer HealthCare Pharmaceuticals' Yasmin. Additionally, FDA approved levonorgestrel tablet (Glenmark Pharmaceuticals), 1.5 mg, the generic version of Plan B One-Step tablet of Teva Branded Pharmaceutical Products R&D.