Aurobindo Pharma bags USFDA okay for Duchenne muscular dystrophy drug Deflazacort

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-02-13 06:29 GMT | Update On 2024-03-21 15:30 GMT

Hyderabad: Aurobindo Pharma Limited has announced that the Company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), EMFLAZA tablets 6 mg, 18 mg, 30 mg and 36 mg of PTC Therapeutics Inc.

The product will be launched in February 2024. The approved product has an estimated market size of US$ 67 million for the three months ending September 2023, according to PTC Therapeutics Inc.

Aurobindo now has a total of 502 ANDA approvals (482 Final approvals and 20 tentative approvals) from USFDA.

Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.

Duchenne muscular dystrophy (DMD) is a severe type of muscular dystrophy mainly impacting males. Onset of muscle weakness typically begins around age four and progresses rapidly. Initial muscle deterioration often affects the thighs and pelvis before spreading to the arms, leading to difficulties in standing up. By around age 12, most individuals affected by DMD lose the ability to walk. Affected muscles may appear enlarged due to increased fat content, and scoliosis is a common complication. Some individuals may also experience intellectual disabilities.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.

The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Aurobindo Pharma bags USFDA okay for Duchenne muscular dystrophy drug Deflazacort

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