 "Zydus Lifesciences")
Zydus Lifesciences said on Tuesday that it has received the United States Food and Drug Administration (USFDA) nod for Varenicline Tablets and Diclofenac Sodium/Misoprostol delayed release tablets in the US. These drugs are indicated for treating smoking addiction and osteoarthritis respectively.
The stock for Zydus Lifesciences rose 1.52 percent on BSE to Rs 517.70 per share.
Manufactured at Zydus' formulation manufacturing facility in Ahmedabad, Varenicline Tablets will be launched soon in the US. According to IQVIA MAT data from March 2023, the US market for Varenicline tablets generated annual sales of $501 million.Additionally, Zydus has also received final approval for Diclofenac Sodium and Misoprostol delayed release tablets, which will be used for the treatment of osteoarthritis and rheumatoid arthritis in individuals at high risk of developing stomach or intestinal ulcers.The annual sales of Diclofenac Sodium and Misoprostol Delayed Release Tablets in the US were reported to be $13 million, according to IQVIA MAT data from March 2023.
Zydus now has a total of 374 approvals from the USFDA and has filed over 442 Abbreviated New Drug Applications (ANDAs) since the beginning of the filing process in the fiscal year 2003-04.
