1. Generics Bulletin
  2. >>Products

Par Steps In With Chantix Rival After Pfizer Recall

Endo Unit’s Launch Of US Varenicline Tablets Comes After Early Approval

 
• By Dave Wallace

Endo’s Par generics unit has launched the first US generic version of Pfizer’s Chantix (varenicline) tablets, entering the market just after the originator recalled the brand over nitrosamine impurities.

Chantix pack Varenicline
Chantix was recalled ahead of Par’s generic launch • Source: Alamy

Endo’s Par unit has launched the first US generic rival to Pfizer’s (varenicline) tablets, coinciding with current shortages of the product after the originator recalled the brand due to the discovery of nitrosamine impurities.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Products

Sandoz Attacks Amgen Over US Enbrel Exclusivity

 
• By Dave Wallace

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."

Cipla Welcomes Abraxane ANDA Approval After Tackling Goa Compliance Issues

 
• By Dean Rudge

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

Biocon Celebrates Long-Awaited FDA Approval For Bevacizumab Biosimilar

 
• By Urtė Fultinavičiūtė

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.

US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

 
• By Urtė Fultinavičiūtė

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

More from Generics Bulletin

US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

 
• By Urtė Fultinavičiūtė

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

Jazz Agrees To Fork Out $145m To Resolve Most Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.