Zydus Lifesciences secures USFDA okay for Duchenne Muscular Dystrophy drug

Duchenne Muscular Dystrophy is a genetic disorder characterized by progressive muscle degeneration and weakness. It is one of the most severe forms of muscular dystrophy and primarily affects boys, although in rare cases, it can affect girls as carriers.

The newly approved Deflazacort oral suspension will be produced at Doppel, Italy.

The group now has 424 approvals and has so far filed 487 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04.

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This approval follows a previous approval for Duchenne muscular dystrophy drug in April when the company received final approval from the USFDA to manufacture Jaythari (Deflazacort) Tablets, 6 mg, 18 mg, 30 mg, and 36 mg (USRLD: Emflaza Tablets, 6 mg, 18 mg, 30 mg, and 36 mg). 

Read also: Zydus Lifesciences bags USFDA nod for Duchenne muscular dystrophy drug Jaythari

Zydus Lifesciences Ltd. is a global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.