Lupin bags USFDA nod for generic equivalent of Slynd Tablets

Mumbai: Global pharma major Lupin Limited today announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg.

The product is a generic equivalent of Slynd Tablets, 4 mg, of Exeltis USA Inc. SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.

Drospirenone Tablets (RLD Slynd) had estimated annual sales of USD 141 million in the U.S. (IQVIA MAT September 2022).

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women's health areas. Lupin invested 8.7% of its revenue in research and development in FY22.