USFDA gives tentative nod for Lupin diabetes drug Sitagliptin
Mumbai: Global pharma major Lupin Limited has announced
that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA)
for its Abbreviated New Drug Application (ANDA), Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg
to market a generic equivalent of Januvia Tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharp and
Dohme Corp.
This product will be manufactured at Lupin’s Pithampur facility in India.
Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to
improve glycemic control in patients with type 2 diabetes mellitus.
Sitagliptin Tablets (RLD Januvia) had estimated annual sales of USD 5789.3 million in the U.S. (IQVIA
MAT October 2023).
Medical Dialogues team had earlier reported that the Company had received tentative approval from the USFDA for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga Tablets, 5 mg, and 10 mg of AstraZeneca AB.
Read also: Lupin Dapagliflozin Tablets gets tentative USFDA okay
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, gastro-intestinal (GI), central nervous system (CNS), and women’s
health areas. The company
invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
Read also: Lupin Diagnostics unveils Regional Reference Laboratory in Chennai
