Lupin bags USFDA nod for Sildenafil for Oral Suspension

Mumbai: Global pharma major, Lupin Limited, has recently announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Sildenafil for Oral Suspension, 10 mg/mL. 

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.

The product is a generic equivalent of Revatio for Oral Suspension, 10 mg/mL, of Viatris Specialty LLC. The product will be manufactured at Lupin's facility in Goa, India.

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Sildenafil is a medication used to treat erectile dysfunction and pulmonary arterial hypertension.

Sildenafil for Oral Suspension, 10 mg/mL (RLD Revatio) had estimated annual sales of USD 66 million in the U.S. (IQVIA MAT December 2021).

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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 enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. 

The company invested 9.6% of its revenue in research and development in FY21.

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