Lupin gets US FDA nod for Tydemy tablets

The drug is indicated for use by women to prevent pregnancy

Lupin has launched its Tydemy tablets, indicated for use by women to prevent pregnancy, in the US. The launch follows the approval from the US Food and Drug Administration (US FDA) of Tydemy tablets (Drospirenone, Ethinyl Estradiol, Levomefolate Calcium, 3mg/ 0.03mg/ 0.451mg and Levomefolate Calcium, 0.451mg), the company said in a statement.

The approved Tydemy tablets are generic equivalents of Bayer HealthCare Pharmaceuticals’ Safyral tablets, Lupin said. The medicine 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, it added.