Lupin gets USFDA nod for generic oral contraceptive pill

The company has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Drospirenone Tablets in 4 mg strength, said the drug maker.
An employee of Lupin Limited works at a reception at their headquarters in Mumbai. (File Photo | Reuters)
An employee of Lupin Limited works at a reception at their headquarters in Mumbai. (File Photo | Reuters)

NEW DELHI: Drug maker Lupin on Friday said it has received approval from the US health regulator to market Drospirenone tablets, used to prevent pregnancy, in the American market.

The company has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Drospirenone Tablets in 4 mg strength, the Mumbai-based drug maker said in a statement.

The company's product is the generic equivalent of Exeltis USA Inc's Slynd tablets, it added.

As per IQVIA MAT September 2022 data, Drospirenone tablets had estimated annual sales of USD 141 million in the US market.

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