PRINCETON, N.J. — Dr. Reddy’s path to excelling in the manufacture of complex generics and biosimilars depends on its successful filing for new drugs — be these formulations or active pharmaceutical ingredients (APIs). In fiscal 2020, the company filed eight new Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration. As of March
PRINCETON, N.J. — Dr. Reddy’s Laboratories and its subsidiary, Promius Pharma. today announced the approval of Tosymra (previously known as DFN-02) by the U.S. Food and Drug Administration (FDA). Tosymra is indicated for the acute treatment of migraine with or without aura in adults. Tosymra is the latest product to join the Promius Pharma acute migraine treatment
HYDERABAD, India, and PRINCETON, N.J. — Dr. Reddy’s Laboratories plans to buy eight Abbreviated New Drug Applications (ANDAs) in the United States from Teva Pharmaceutical Industries Ltd. and an affiliate of Allergan plc for $350 million in cash. Dr. Reddy’s, which announced the agreement over the weekend, said the acquired products are being divested by
PRINCETON, N.J. — Promius Pharma LLC has received Food and Drug Administration approval for Sernivo Spray 0.05%, a psoriasis medication. A prescription topical steroid, Sernivo Spray (betamethasone dipropionate 0.05%) is indicated for the treatment of mild to moderate plaque psoriasis in adult patients, according to Promius, the U.S. subsidiary of India-based Dr. Reddy’s Laboratories. “The
