Lupin gets US FDA nod for Doxycycline Hyclate Delayed-Release Tablets USP

Lupin Limited announced that it has received FDA approval for its Abbreviated New Drug Application for doxycycline hyclate delayed-release tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, to market a generic equivalent of Mayne Pharma's Doryx delayed-release tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx MPC delayed-release tablets, 60.Lupin's Pithampur facility in India will manufacture this product.Doxycycline hyclate delayed-release tablets USP (Doryx ) had estimated annual sales of USD 9 million in the US (IQVIA MAT June 2023).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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.