The FDA has approved two pain medications: meloxicam in an injection and over-the-counter diclofenac sodium topical gel 1%…
IV Meloxicam Stalls at FDA; Plus Health Canada Approves Risankizumab for Plaque Psoriasis
In a second response letter, the FDA has cited the onset and duration of intravenous meloxicam, a non-opioid pain treatment, as concerns that it fails to meet prescriber expectations…
FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones
The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…
Revised Application Expected for IV Meloxicam; Plus EU Approves Tildrakizumab
After meeting with the FDA, the makers of intravenous meloxicam plan to resubmit the treatment’s new drug application…
IV Tramadol Promising for Postoperative Pain; FDA Denies IV Meloxicam Approval
In its first phase 3 clinical trial, intravenous tramadol has met its primary endpoint for relieving postoperative pain…
Recro Pharma’s Non-Opioid Pain Shot Fails to Get Approval from FDA
(Reuters)—Recro Pharma’s IV meloxicam, a non-opioid injection, did not get approval from the U.S. Food and Drug Administration because the agency said the drug’s pain-relieving effect did not meet its expectations. The company said it plans to meet with the FDA to find solutions. Unlike the drug’s oral version, which has been on the market…
Pain Treatments Move Closer to U.S. Market
Two pain treatments, extended-release injectable suspension triamcinolone acetonide (Zilretta) and meloxicam, have seen movement at the U.S. Food and Drug Administration (FDA). In October, the agency approved Zilretta to treat osteoarthritis (OA) knee pain and accepted a new drug application for meloxicam to treat pain. FDA Approves Zilretta On Oct. 6, the FDA approved extended-release,…
Patients with OA Respond to Low-Dose SoluMatrix Meloxicam; Off-Label Use of Ketoconazole Results in Death
In a clinical trial, patients with osteoarthritis taking low-dose SoluMatrix meloxicam used less rescue medication to manage pain. Also, the FDA has issued a new warning against using oral ketoconazole off label to treat onychomycosis and fungal skin infections…