In other generic news, the FDA has approved generics of the osteoporosis drug Forteo and Amneal is developing a generic version of Vascepa.
Lupin has received approval from the FDA for its abbreviated new drug application for Varenicline Tablets, 0.5 mg and 1 mg, a generic equivalent of Chantix, which is used as an aid to smoking cessation treatment. The product will be manufactured at Lupin’s Pithampur facility in India.
The branded Chantix was developed by Pfizer. In 2021, Pfizer initiated a series of recalls of all Chantix because of presence of a nitrosamine, which may be associated with an increased risk of cancer. The company also stopped all production of the product.
A Pfizer spokesperson said they are working to reformulate Chantix and progress discussions with regulators to remediate stock-outs. Previously, Pfizer proposed to major regulators, including the FDA and EMA, short and medium-term plans to enable supply to patients. "Pfizer is working to compile the data requested by FDA and EMA that would allow the regulators to more thoroughly assess resupply options. While we are working expeditiously, Pfizer cannot speculate on resupply timing at this time," the spokesperson said.
In other generic news:
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.