Keeping Track: Teva's Austedo Clears US FDA, Merck Sitagliptin CV Outcomes Labeling Draws Complete Response

The latest drug development news and highlights from our FDA Performance Tracker.

Keeping Track Feature image

FDA's Division of Neurology Products continued its hot streak in 2017 with the approval of Teva Pharmaceutical Industries Ltd.'s Austedo (deutetrabenazine), the fourth novel agent to clear the division this year.

Austedo brings the novel approvals count from the Center for Drug Evaluation and Research (CDER) to 13 in 2017. The...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from Approvals

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

Argentina Speeds Up Market Access Process

 

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Product Reviews

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By 

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

Infographic: Leqembi – A Geographical Comparison

 

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.