Drug firm Zydus Cadila on Friday said it has received final approval from the US health regulator to market Dimethyl Fumarate delayed-release capsules, indicated for the treatment of patients with relapsing forms of multiple sclerosis. Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Dimethyl Fumarate delayed release capsules, (Tecfidera)in the strengths of 120 mg and 240 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing.
Zydus Cadila said in its approval, the USFDA noted that Zydus was one of the first abbreviated new drug application 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 favour 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 company added.
Zydus Cadila said the newly approved medication will be manufactured at the group’s formulation manufacturing facility at the SEZ, Matoda. The group now has 303 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in 2003-04.
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Cipla on Friday said it has also received final approval from the USFDA for dimethyl Fumarate capsules. Quoting IQVIA (IMS Health) data, Cipla said Tecfidera had US sales of approximately USD 3.8 billion for the 12-month period ending July 2020.
Shares of Cadila Healthcare were trading 0.39per cent lower at Rs 377.50 apiece on BSE.