Copaxone 40mg Generic: FDA Exceeds Mylan's Expectations

FDA approves the product well before Mylan's prediction of 2018.

StacksOfPapers_1200x675
This is not an image of an electronic application.

FDA beat Mylan NV's expectations for the approval of its Copaxone generic, even though it appears that the agency may have missed the target date that had been set.

Mylan surprised investors late Oct. 3 when it announced the approval of its substitutable generic of Teva Pharmaceutical Industries...

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

New EU Filings

 

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 

The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, 1H 2025 saw a 30% rise in new active substance approvals compared to the same period last year.

Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By 

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

More from Product Reviews

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 

The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, 1H 2025 saw a 30% rise in new active substance approvals compared to the same period last year.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By 

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.