Glenmark receives two ANDA approvals from USFDA

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, the generic version of Yasmin Tablets of Bayer Healthcare Pharmaceuticals Inc. (Bayer) and for Levonorgestrel Tablet, 1.5 mg, the generic version of Plan B One-Step Tablet of Teva Branded Pharmaceutical Products R&D, Inc., for over-the-counter (OTC) use as recommended in the submitted labeling.

According to IMS Health sales data for the 12 month period ending January 2016, the Yasmin market achieved annual sales of approximately $131.7 million while the Plan B One-Step Tablet OTC market achieved annual sales of approximately $45.2 million.

Glenmark’s current portfolio consists of 112 products authorized for distribution in the US marketplace and 57 ANDA’s pending approval with the USFDA.