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

Fix it or exit: India gives Deanxit and generics 6-month deadline

 
• By Anju Ghangurde

The Drugs Controller General of India (DCGI) has set a six month deadline for manufacturers of the controversial fixed dose combination (FDC) of flupenthixol and melitracen (Lundbeck’s Deanxit) to establish the safety and efficacy of their products in India, with the threat of prohibition if they fail.

The Drugs Controller General of India (DCGI) has set a six month deadline for manufacturers of the controversial fixed dose combination (FDC) of flupenthixol and melitracen (Lundbeck’s Deanxit) to establish the safety and efficacy of their products in India, with the threat of prohibition if they fail.

Deanxit has been under the spotlight in India for considerable time now, more so after a Parliamentary Committee report last...

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

Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 
• By Andrew McConaghie

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Vigil’s Iluzanebart Disappoints In Rare Neurodegenerative Disease

 
• By Jessica Merrill

The Phase II TREM2 agonist is not part of Sanofi’s planned acquisition.

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By Kevin Grogan

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

More from Therapeutic Category

Early Blood Cancer Data Impresses As Incyte Plots Post-Jakafi Strategy

 
• By Kevin Grogan

First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 
• By Andrew McConaghie

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.