Zydus receives tentative approval from the USFDA for Levomilnacipran Extended-Release Capsules

Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus) has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, and 120 mg (USRLD: Fetzima® Extended-Release Capsules).

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults. The drug will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, India.

Levomilnacipran Extended-Release Capsules had annual sales of USD 85 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).

The group now has 341 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 441.25 as compared to the previous close of Rs. 448.05. The total number of shares traded during the day was 21770 in over 1055 trades.

The stock hit an intraday high of Rs. 449.50 and intraday low of 440.00. The net turnover during the day was Rs. 9639869.00.

(*as of 30th September 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 TentativeApproval ZydusPharmaceuticalsUSA USFDA Levomilnacipran ExtendedRelease Capsules