Posted by Michael Wonder on 18 Dec 2024
Tonix Pharmaceuticals announces FDA acceptance of the new drug application for TNX-102 SL for fibromyalgia
17 December 2024 - FDA is expected to assign a PDUFA target action date and announce whether priority review has been granted in the Day 74 letter.
Tonix Pharmaceuticals today announced that the US FDA has accepted the filing of its new drug application for TNX-102 SL (cyclobenzaprine hydrochloride sublingual tablets), a 5.6 mg, non-opioid, centrally-acting analgesic, for the management of fibromyalgia.
