Lupin receives USFDA’s approval for generic Safyral Tablets

14 Dec 2017 Evaluate

Lupin has received final approval for its Tydemy (Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg) from the United States Food and Drug Administration (USFDA) to market a generic version of Safyral Tablets of Bayer HealthCare Pharmaceuticals Inc. Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg tablets had annual sales of around $22.9 million in the US, as per IMS MAT October 2017.

The company’s Tydemy (Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg) is the AB rated generic equivalent of Safyral Tablets of Bayer HealthCare Pharmaceuticals Inc. Tydemy is indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.



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