Dr Reddy's Laboratories Limited has announced the U. S. Food and Drug Administration (US FDA) final approval for the Company's Abbreviated New Drug Application (ANDA) for Tizanidine Hydrochloride tablets 2 mg and 4 mg. The product will be shipped immediately and marketed though the Company's alliance partner, Par Pharmaceuticals, stated a company release.

Tizanidine hydrochloride is the AB-rated generic equivalent of Elan Corporation's Zanaflex. Zanaflex is indicated for the management of increased muscle tone associated with spasticity, a condition affecting the central nervous system (CNS) causing muscle stiffness and rigidity. As per IMS 2001, the product had annual US brand sales of approximately $160 million.

Dr. Reddy's is an emerging global pharmaceutical company with proven basic research capabilities. The company develops, manufactures and markets a wide range of pharmaceutical products in India and overseas. Dr. Reddy's produces finished dosage forms, active pharmaceutical ingredients, diagnostic kits, critical care and biotechnology products. The basic research programme of Dr. Reddy's focuses on cancer, diabetes, bacterial infections and pain management.