Indoco Remedies Varenicline Tablets gets USFDA nod to aid smoking cessation treatment
Mumbai: Indoco Remedies Ltd. has announced the final approval of the Company's Abbreviated New Drug Application (ANDA) for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent to the reference listed drug (RLD), Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF) from USFDA.
Varenicline Tablets, 0.5 mg and 1 mg bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF).
This product, Varenicline Tablets, 0.5 mg and 1 mg will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.
Varenicline is used to aid smoking cessation treatment.
Commenting on the achievement, Aditi Panandikar, Managing Director said, “Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US.”
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