Cadila Healthcare gets final approval for sclerosis drug

Cadila Healthcare rose 0.39% to Rs 377.50 after the company said it received US drug regulator's final approval for Dimethyl Fumarate delayed-release capsules.

Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Dimethyl Fumarate delayed-release capsules, (US RLD: Tecfidera) in the strengths of 120 mg and 240 mg. In its approval, the USFDA noted that Zydus was one of the first abbreviated new drug application (ANDA) applicants to submit a substantially complete ANDA and is therefore eligible for 180 days of generic drug exclusivity along with other first ANDA applicants.

The USFDA granted approval following entry of judgment in favor of Zydus Cadila and other ANDA applicants by the United States District Court for the District of Delaware, holding that the only unexpired patent covering Tecfidera is invalid. Dimethyl Fumarate delayed-release capsules are indicated for the treatment of patients with relapsing forms of multiple sclerosis and will be manufactured at the group's manufacturing facility at the SEZ, Matoda.

The group now has 303 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

Cadila Healthcare is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

On a consolidated basis, the company's net profit surged 49.53% to Rs 454 crore on 4.20% rise in revenue from operations to Rs 3,549.30 crore in Q1 June 2020 over Q1 June 2019.

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