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  • USFDA approves Zydus...

USFDA approves Zydus Varenicline Tablets for smoking addiction treatment

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-06-13T17:30:48+05:30  |  Updated On 13 Jun 2023 5:31 PM IST
USFDA approves Zydus Varenicline Tablets for smoking addiction treatment
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Ahmedabad: Zydus Lifesciences Limited has announced that the company 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 product will be launched shortly. Varenicline tablets are indicated to treat smoking addiction.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Commenting 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.”

Varenicline Tablets, 0.5 mg and 1 mg had annual sales of USD 501 mn in the United States (IQVIA MAT Mar. 2023). The group now has 374 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

Recently, Medical Dialogues has reported that the company has also received final approval from the USFDA to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg (USRLD: Arthrotec Delayed-Release Tablets).

Read also: Zydus Lifesciences wins USFDA nod for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Zydus Lifesciences Limited, Formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.

Read also: Zydus gets USFDA nod for bowel disease drug Balsalazide Disodium

zydus lifescienceszydus lifesciences newsvarenicline tabletschantix tabletssmokingusfda
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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