Zydus receives tentative approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received tentative approval from the United States Food and Drug Administration (USFDA) to market Diroximel Fumarate Delayed-Release Capsules, 231 mg (USRLD: Vumerity® Delayed-Release Capsulestablets).

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, India.

Diroximel Fumarate Delayed-Release Capsules had annual sales of USD 847.4 mn in the United States (IQVIA MAT May 2024).

The group now has 398 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 1180.40 as compared to the previous close of Rs. 1166.20. The total number of shares traded during the day was 45051 in over 4345 trades.

The stock hit an intraday high of Rs. 1190.00 and intraday low of 1133.55. The net turnover during the day was Rs. 52158786.00.

(*as of 31st March 2024)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 TentativeApproval USFDA DiroximelFumarate DelayedRelease Capsules