Aurobindo Pharma gets tentative USFDA approval for multiple sclerosis treatment drug

The United States Food and Drug Administration (USFDA) has given Aurobindo Pharma preliminary approval for Dimethyl Fumarate capsules, which are used to treat multiple sclerosis. The USFDA has granted approval for 120 mg and 240 mg capsules. Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg are bioequivalent and therapeutically equivalent to Biogen Inc.’s Tecfidera Delayed-Release Capsules, 120 mg and 240 mg.

Adults with relapsing forms of multiple sclerosis are treated with dimethyl fumarate. Clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease are all examples of this. Because of the patent issue, the USFDA granted tentative approval rather than final approval. Aurobindo Pharma’s wholly owned subsidiary Eugia Pharma Specialities received final approval from the US Food and Drug Administration last month for Amphotericin B Liposome injection, which is used to treat fungal infections.

Furthermore, Acrotech Biopharma, a subsidiary of the company, has entered into a licence agreement with global biopharmaceutical company Evive Biotech to commercialise Ryzneuta in the United States. Ryzneuta is being developed to treat Chemotherapy-Induced Neutropenia (CIN) in cancer patients following chemotherapy.

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