Friday, 23 February 2018

Lupin receives FDA approval for generic Safyral Tablets

02 January 2018 | News

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

Pharma Major Lupin recently announced that it 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 (FDA) to market a generic version of Safyral Tablets of Bayer HealthCare Pharmaceuticals Inc.

Lupin’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.

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 approximately USD 22.9 million in the US. (IMS MAT October 2017).

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