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FDA Approves Generic of Chantix, Pfizer's Smoking Cessation Drug
This is the first approval of generic version of Chantix, and it comes just weeks after a recall of the brand-name drug.
The FDA has approved the first generic version of Chantix (varenicline), Pfizer's smoking cessation product. Developed by Par Pharmaceutical, which is part of Endo International, the generic varenicline tablet was approved August 11, 2021. The generic will come in doses of 0.5 mg and 1 mg.
The approval of generic Chantix comes just a month after Pfizer stopped distribution and initiated a recall of Chantix because of high levels of a nitrosamine impurity, called N-nitroso-varenicline. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans. Pfizer expanded the initial recall from nine lots to 12.
The FDA allowed temporary importation of a generic from Canada to help meet the demand. for Chantix. Apotex Corp. initiated importation of apo-Varenicline 0.5 mg and 1 mg tablets into the U.S. market to address a shortage of the drug.
Related: Apotex to Import Generic of Chantix from Canada
Apo-Varenicline is the varenicline tartrate product approved by Health Canada as a generic equivalent to Champix tablets manufactured by Pfizer Canada. Champix is the brand name of Chantix in Canada.
According to an FDA spokesperson, this importation was not related to the Safe Importation Action Plan, which became effective November 30, 2020. In this case, the FDA exercised regulatory flexibility and discretion to address drug shortages and mitigate any significant risk to patients.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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