Zydus Cadila has received final approval from the USFDA to market Dimethyl Fumarate DelayedRelease 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 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.
Shares of CADILA HEALTHCARE LTD. was last trading in BSE at Rs.376.05 as compared to the previous close of Rs. 383.9. The total number of shares traded during the day was 110488 in over 2727 trades.
The stock hit an intraday high of Rs. 383.8 and intraday low of 373.95. The net turnover during the day was Rs. 41874067.