Lupin gets USFDA nod for generic equivalent of Oracea Capsules
ORACEA is a tetracycline class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Mumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Doxycycline Capsules, 40 mg.
The product is a generic equivalent of Oracea Capsules, 40 mg, of Galderma Laboratories, L.P.
ORACEA is a tetracycline class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Doxycycline Capsules (RLD Oracea) had estimated annual sales of USD 215 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.
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