21 August 2015 | News | By BioSpectrum Bureau
Glenmark's new generic gets FDA nod
Singapore: Glenmark Pharmaceuticals(Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg. The drug is the generic version of Yaz Tablets of Bayer HealthCare Pharmaceuticals (Bayer).
Glenmark plans to commence shipping of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg immediately.
According to IMS Health sales data for the 12 month period ending June 2015, the Yaz market achieved annual sales of approximately $170.1 million.