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Glenmark Pharmaceuticals’ Generic of Leo Pharma’s Enstilar Approved

The FDA has approved Glenmark Pharmaceuticals’ generic version of Leo Pharma’s Enstilar (calcipotriene and betamethasone dipropionate), for topical treatment of plaque psoriasis.

Calcipotriene is a vitamin D analog and betamethasone dipropionate is a corticosteroid.

Glenmark’s abbreviated new drug application (ANDA) received paragraph IV certification that allows the company to market a generic before the expiration of patents related to the brand-name drug.

Under the terms of the ANDA approval, Glenmark’s product is eligible for 180 days of generic drug exclusivity.

Glenmark Pharmaceuticals Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, India. It was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons. The company initially sold its products in India, Russia, and Africa. The company went public in India in 1999, and used some of the proceeds to build its first research facility. Saldanha's son Glenn took over as CEO in 2001, having returned to India after working at PricewaterhouseCoopers. By 2008 Glenmark was the fifth-biggest pharmaceutical company in India.

March 29, 2023

https://www.fdanews.com/

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