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Find Clinical Drug Pipeline Developments & Deals for Diclofenac Sodium
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 2%, TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG, TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG, SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1%, SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
The launch of Dr. Reddy’s Diclofenac Sodium Topical Gel, 1% (OTC), is an important addition to the Pain/ Analgesics portfolio of OTC products, and represents the continued commitment to the Private Label OTC space.
DARE-PDM1 is a novel delivery of the diclofenac sodium, a NSAID drug which inhibits COX-1 and COX-2 responsible for producing PGs which contributes in inflammation and pain signalling. It uses Daré’s proprietary hydrogel technology targeted at treating primary dysmenorrhea.
Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential to be a first-in-category product.
Diclofenac topical solution is used to treat pain and swelling caused by osteoarthritis of the knees. Diclofenac Sodium Topical Solution, 2% w/w (RLD PENNSAID®) had estimated annual sales of USD 509 million in the U.S.
This phase 2/3 multi-center, randomized, double-blind trial investigated the effect of a new 3.06% diclofenac sodium gel formulation (AMZ001) for the relief of knee OA pain, in 444 patients exposed to either AMZ001 once daily (QD), AMZ001 twice daily (BID) or placebo.