Receives final USFDA approval for varenicline tablets

Zydus Lifesciences Limited has announced that it has received final approval from the United States Food and Drug Administration (US FDA) to manufacture and market varenicline tablets, 0.5 mg and 1 mg (USRLD: Chantix tablets).

Varenicline tablets are indicated to treat smoking addiction.The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, said the company.

According to IQVIA MAT March 2023, varenicline Tablets, 0.5 mg and 1 mg, had yearly sales of $ 501 million in the United States.

With this, the group now has 374 approvals and has so far filed over 442 ANDAs as of December 31, 2022, since the commencement of the filing process in FY 2003–04.

Earlier in May, Zydus received final approval to manufacture and market ephedrine sulfate injection USP, 50 mg/mL single-dose vials.
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anaesthesia.