Last Updated on October 14, 2024 by The Health Master
Ahmedabad: Zydus Lifesciences Limited (Zydus) has announced that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Varenicline Tablets, 0.5 mg and 1 mg (USRLD: Chantix Tablets).
The company will launch the product shortly. The treatment of smoking addiction is indicated with Varenicline tablets.
The Zydus group’s formulation manufacturing facility in Ahmedabad SEZ, India, will produce the medication.
Speaking on the approval, Dr Sharvil Patel, Managing Director, Zydus Lifeciences Limited, said, “We are pleased with the approval and imminent launch of generic Verinicline, which validates the agility of our supply chain as well as the focused efforts by our R&D team, which will improve access and availability of the generic product for patients in the US market.”
“This an important product which will support our growth plans in US market in the current fiscal.”
In the United States, Varenicline tablets, 0.5 mg and 1 mg, had annual sales of $ 501 million (IQVIA MAT Mar 2023).
Zydus informed that the group now has 374 approvals and has so far filed over 442 ANDAs as of March 2023, since the commencement of the filing process in FY 2003–04.
USFDA gives approval for Levetiracetam Tablets
USFDA gives approval for Metoprolol Succinate ER Tablets
USFDA gives approval for Cisatracurium Besylate injection
USFDA gives nod for Esomeprazole Magnesium Suspension
USFDA concludes inspection at Zydus with zero observation
DTAB recommendation: On presence of banned antibiotics in food producing animals
Codeine cough syrup worth Rs 35 lakh seized: Maharashtra
DTAB: Proposal to Amend Medical Devices Rules for Hospital Imports
Guidance documents for industry
USFDA completes inspection of Dr Reddy’s with zero observation
PCI and IPA join hands to enhance quality of Pharmacy Education
USFDA issues Form 483 with 11 observations IPCA Labs: Ratlam
UP Govt Drafts Pharmaceutical Industry Policy 2023: Details
Safe Disposal of Unused Drugs: Urgent Need a Comprehensive Policy
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
