Glenmark gains FDA approval for new generic

Glenmark's drug is the generic version of Janssen Pharmaceuticals

Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg.

Glenmark's drug is the generic version of Ortho Tri-Cyclen Lo Tablets of Janssen Pharmaceuticals.

According to IMS Health sales data for the 12 month period ending December 2015, the Ortho Tri-Cyclen Lo Tablets market1 achieved annual sales of approximately $503.9 million.

Glenmark's current portfolio consists of 107 products authorized for distribution in the US marketplace and 62 ANDA's pending approval with the FDA.