Aurobindo Pharma Limited has achieved a significant milestone with the receipt of final approval from the US Food and Drug Administration (USFDA) for the manufacture and marketing of Deflazacort Tablets in various strengths. 

These tablets, available in 6 mg, 18 mg, 30 mg, and 36 mg formulations, are deemed bioequivalent and therapeutically equivalent to the reference listed drug (RLD), EMFLAZA® tablets, by PTC Therapeutics Inc. The company plans to launch the product in February 2024.

With this latest approval, the company's portfolio now comprises a total of 502 ANDA approvals from the USFDA, comprising 482 final approvals and 20 tentative approvals.

Deflazacort Tablets are specifically indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 5 years and older. This approval represents a significant advancement in the availability of treatment options for individuals affected by this debilitating condition.

According to PTC Therapeutics Inc., the estimated market size for Deflazacort Tablets for the three months ending September 2023 is approximately USD 67 million. Aurobindo Pharma's entry into this market segment is poised to address the growing demand for therapeutically equivalent alternatives and provide patients with access to effective treatment options.

Aurobindo Pharma's ongoing commitment to innovation, coupled with its extensive portfolio of FDA-approved products, positions the company as a key player in the global pharmaceutical industry.