Zydus Cadila gets USFDA nod for multiple sclerosis drug
Ahmedabad: Drugmaker, Zydus Cadila, has recently announced that the company has received final approval from the U.S. Food and Drug Administration (USFDA) to market Dimethyl Fumarate DelayedRelease Capsules, (US RLD: Tecfidera®) in the strengths of 120 mg and 240 mg.
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.
In its approval, the USFDA noted that Zydus was one of the first 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.
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.
Read also: Zydus Cadila anti-cancer drug Palbociclib gets tentative USFDA nod
Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India.
The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.
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