Zydus Lifesciences bags USFDA nod for Duchenne muscular dystrophy drug Jaythari
Ahmedabad: Pharma major, Zydus Lifesciences Limited 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.
Duchenne Muscular Dystrophy (DMD) 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.
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.
Medical Dialogues team had earlier reported that the Company had also received final approval from the USFDA to manufacture Apalutamide Tablets, 60 mg (Erleada Tablets, 60 mg). Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
Read also: Zydus Lifesciences bags USFDA nod for prostate cancer drug Apalutamide
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
