Monthly Prescribing Reference

Meloxicam Tablets Mislabeled as Cyclobenzaprine HCl Prompt Recall

The recall involves Lot# GMML24026A (NDC# 29300-415-19) with an expiration date of September 2027. Unichem Pharmaceuticals is recalling 1 lot of Cyclobenzaprine Hydrochloride Tablets USP, 10mg due to ...
Seeking Alpha

Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

CHATHAM, N.J., Aug. 15, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) ...
Healio

FDA grants fast track designation to cyclobenzaprine tablets for fibromyalgia

Please provide your email address to receive an email when new articles are posted on . Tonmya significantly reduced daily pain vs. placebo in a phase 3 trial in fibromyalgia. Fast track designation ...
Medscape

FDA Approves First-in-Class Drug for Fibromyalgia

The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals), a first-in-class, nonopioid treatment for adults with fibromyalgia, a chronic pain syndrome that ...