The FDA has accepted a New Drug Application (NDA) for TNX-102 SL, Tonix Pharmaceuticals’ cyclobenzaprine hydrochloride sublingual tablets, a 5.6-mg, nonopioid, centrally acting analgesic, for the management of fibromyalgia.
The FDA has assigned the NDA a Prescription Drug User Fee Act target action date of August 15. At that time, the FDA will also communicate to Tonix whether a Priority Review designation has been granted. TNX-102 SL was granted Fast Track designation for