1. Scrip
  2. >>Therapy Areas
  3. >>Neurological

FDA denies Teva's 7th petition to stop generic Copaxone

 
• By Donna Young

The FDA, for the seventh time, has denied a citizen petition from Israeli drug maker Teva requesting US regulators not approve an abbreviated new drug application (ANDA) that references the company's multiple sclerosis (MS) drug Copaxone (glatiramer acetate injection) unless certain conditions are satisfied.

The FDA, for the seventh time, has denied a citizen petition from Israeli drug maker Teva requesting US regulators not approve an abbreviated new drug application (ANDA) that references the company's multiple sclerosis (MS) drug Copaxone (glatiramer acetate injection) unless certain conditions are satisfied.

The FDA told Teva the agency would not comment on the approvability of any application for any glatiramer acetate injection...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Neurological

Roche Unveils Alzheimer’s Phase III Plan And Preclinical Study

 
• By Andrew McConaghie

The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.

Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

 
• By Alaric DeArment

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

Alkermes To Advance Alixorexton After Positive Phase II Narcolepsy Results

 
• By Alaric DeArment

The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.

Insmed’s New R&D Site Focused On ‘Synthetic Rescue’

 
• By Andrew McConaghie

A new small-molecule approach to turning on beneficial genes to counteract disease-causing mutations is being pioneered by Insmed’s UK-based scientists.

More from Therapy Areas

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

Viking Rapidly Advancing Oral And Injectable VK2735 For Obesity

 
• By Joseph Haas

In its Q2 update, Viking reported that Phase III trials of subcutaneous VK2735 are under way, and that it expects Phase II data for an oral formulation before year’s end.