Lupin Gets Approval for Chantix Generic

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:

• Amneal Pharmaceuticals is partnering with Strides Pharma Science to commercialize ofIcosapent ethyl acid soft gel capsule, a generic of Vascepa, which is used to reduce the risk of heart attack and stroke. The generic oflosapent ethyl acid was developed by Strides and will be commercialized by Amneal.
• The FDA approved a generic version of generic version of Forteo (teriparatide injection) developed by Ambio and to be marketed by Apotex. It is used to treat osteoporosis.
• The FDA has the abbreviated new drug application for Milla Pharmaceuticals and its partner Acella Pharmaceuticals generic version of Mestinon (pyridostigmine bromide syrup) 60 mg/5mL. It is indicated for symptomatic treatment of myasthenia gravis, a neuromuscular disorder primarily characterized by muscle weakness and rapid muscle fatigue.
• The FDA has approved Teva’s generic version of Forteo (teriparatide injection), which is indicated to treat osteoporosis among certain women and men. Teva’s generic uses Antares Pharma’s multi-dose pen device. Antares, a wholly owned subsidiary of Halozyme Therapeutics, and Teva have a license, development and supply agreement for Teriparatide auto injector product that Teva markets in the European Union and will market in the United States.
• Teva and Biolojic Design have formed an exclusive license agreement to develop a potential novel antibody-based therapy for the treatment of atopic dermatitis and asthma.