Zydus receives USFDA approval for Jaythari (Deflazacort) Tablets
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (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).
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.
Jaythari (Deflazacort) will be produced at Doppel Farmaceutici S.r.l., Italy facility.
The group now has 424 approvals and has so far filed 492* ANDAs since the commencement of the filing process in FY 2003-04.
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