Zydus receives final approval from the USFDA for Olanzapine Orally Disintegrating Tablets USP

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg (USRLD: Zyprexa Zydis Orally Disintegrating Tablets).

Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg are used to treat certain mental/mood conditions (such as schizophrenia and bipolar disorder). Olanzapine tablets may also be used in combination with other medication to treat depression. These tablets belong to a class of drugs called as atypical antipsychotics and work by helping to restore the balance of certain natural substances in the brain. The products will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad (India).

Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg had annual sales of USD 28.3 mn in the United States (IQVIA MAT Dec. 2022).

The group now has 351 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 474.50 as compared to the previous close of Rs. 468.95. The total number of shares traded during the day was 69189 in over 2856 trades.

The stock hit an intraday high of Rs. 478.50 and intraday low of 465.80. The net turnover during the day was Rs. 32799641.00.

(*as of 31st December 2022)

Source : Equity Bulls

Keywords

ZydusLifeSciences INE010B01027 Pharmaceuticals USFDA FinalApproval OlanzapineOrallyDisintegratingTablets