Zydus Life Receives USFDA Approval for Drug Treating Smoking Addiction

The pharmaceutical company Zydus Lifesciences (NS:ZYDU) has received approval for a drug called Varenicline Tablets from the United States Food and Drug Administration (USFDA), which is used for treating smoking addiction.
The Ahmedabad-headquartered pharma company announced that the US health regulator approved to manufacture and market Varenicline Tablets manufacture and market Varenicline Tablets in the dosage of 0.5 mg and 1 mg.
The drug will be manufactured at Zydus’ formulation manufacturing unit located at Ahmedabad SEZ in India, and shall be launched shortly, the pharmaceutical company said on June 13, 2023.
IQVIA MAT data for March 2023 shows that the annual sales of Varenicline Tablets, 0.5 mg and 1 mg stand at $501 million in the US market.
So far, Zydus Group has received a total of 374 approvals and has filed more than 442 Abbreviated New Drug Applications (ANDAs) since the filing process began in FY04.
Source: Investing