Lupin gets FDA tentative approval for generic of contraceptive pill

Lupin Limited has secured tentative approval for its Abbreviated New Drug Application (ANDA) for Drospirenone Tablets, 4 mg from the US Food and Drug Administration (FDA).

According to the Indian pharma company, Drospirenone Tablets, 4 mg is the generic version of Slynd Tablets, 4 mg of Exeltis USA. Slynd Tablets (drospirenone) is an oral contraceptive.

According to IQVIA MAT September 2022, the estimated annual sales for Drospirenone Tablets in the US is $141 million.