Zydus Life gets tentative USFDA approval to market Letermovir tablets

26 Mar 2024 , 02:16 PM

Zydus Life said on Saturday, March 23, that it has acquired provisional permission from the USFDA to distribute Letermovir tablets in 240 mg and 480 mg strengths.

The tablets are used to prevent disease caused by a virus known as cytomegalovirus in people who have received a bone marrow or kidney transplant, according to a filing with stock exchanges. The company stated that the medication will be produced at its formulation manufacturing plant situated in the Ahmedabad Special Economic Zone (SEZ), India.

The group has collected a total of 393 approvals and has submitted more than 460 Abbreviated New Drug Applications (ANDAs) since initiating the filing process in the fiscal year 2003-04. Sales of the tablets in the United States reached $289.5 Million annually.

The US Food and Drug Administration approved Zydus Life for two injections last week.

In two separate filings with the bourses, the pharmaceutical player stated that it has acquired provisional clearance from the US drug authority for Edaravone Injection as well as final approval for Chlorpromazine Hydrochloride Injection.

In a press release, the pharmaceutical business stated that the USFDA has tentatively approved Zydus Lifesciences, together with its subsidiaries and affiliates, to manufacture and sell Edaravone Injection in a single-dose vial.

Zydus Lifesciences has bagged the final approval from the USFDA for production and marketing of Chlorpromazine Hydrochloride Injection USP, available in concentrations of 25 mg/mL and 50 mg/2 mL (25 mg/mL) single-dose vials.

At around 1.19 PM, Zydus Lifesciences was trading 1.40% higher at ₹1,013.70 per piece, against the previous close of ₹999.75 on NSE. The counter touched an intraday high and low of ₹1,020 and ₹995, respectively.

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