Pfizer Pregabalin Approved For Marketing In Europe; FDA Review Continues
This article was originally published in The Pink Sheet Daily
Executive Summary
The Neurontin follow-on is approved in the EU for neuropathic pain and as add-on therapy for partial seizures in patients with epilepsy. FDA's user fee deadline for pregabalin (Lyrica) is Oct. 30; Neurontin (gabapentin) generics could hit the market prior to pregabalin's approval.
You may also be interested in...
Neurontin Settlement Of $430 Mil. Is High For Off-Label Case, Low For Pfizer
Pfizer's $430 mil. Neurontin off-label promotion settlement is the equivalent of about nine weeks of U.S. sales of the anti-epileptic brand
Teva, Ivax Move Closer To Marketing Generic Gabapentin; Neurontin Litigation Continues
Ivax receives full ANDA approval for low dose tablet formulations of gabapentin. Teva licenses Alpharma's generic exclusivity for capsule form and higher dose tablets.
US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot
ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: