Lupin gets US drug regulator’s nod for generic oral contraceptive pill
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.
Source: Press Trust of India