Lupin gets USFDA nod for generic equivalent of Lyrica Capsules
Pregabalin is used for the treatment of pain caused by nerve damage due to diabetes or shingles infection.
Mumbai: Drugmaker, 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), Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.
The medicine is a generic equivalent of Lyrica Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg of Upjohn US 2 LLC.
Pregabalin is used for the treatment of pain caused by nerve damage due to diabetes or shingles infection.
The product will be manufactured at Lupin's facility in Aurangabad, India. Pregabalin Capsules (RLD Lyrica) had estimated annual sales of USD 263 million in the U.S. (IQVIA MAT March 2022).
Read also: Lupin Diagnostics unveils reference lab in Guwahati
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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.
Read also: Lupin, Yabao Pharma collaborate to meet growing demand for pediatric formulations in China
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