Zydus receives tentative approval from the USFDA for Levothyroxine Sodium for Injection

Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levothyroxine Sodium for injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial (USRLD: Levothyroxine Sodium injection manufactured by Fresenius Kabi USA, LLC).

Levothyroxine Sodium injection is indicated for the treatment of myxedema coma. The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.

Levothyroxine Sodium injection had annual sales of USD 45.2 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022).

The group now has 334 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 401.80 as compared to the previous close of Rs. 392.85. The total number of shares traded during the day was 30623 in over 1209 trades.

The stock hit an intraday high of Rs. 403.95 and intraday low of 392.05. The net turnover during the day was Rs. 12246021.00.

(*as of 30th September 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 ZydusPharmaceuticalsUSA TentativeApproval USFDA LevothyroxineSodium Injection