Study demonstrated systemic exposure of DFD-29 was significantly lower than that of Solodyn (105 mg) Data presented at 43rd Annual Fall Clinical Dermatology Conference New Drug Application...
Zydus Lifesciences on Monday said it has received final approval from the US health regulator for its generic antibiotic Minocycline Hydrochloride extended-release tablets used for treatment of moderate to severe acne. The approval granted by the US Food and Drug Administration (USFDA) is for Minocycline Hydrochloride extended-release tablets of strengths 55 mg, 65 mg, and 115 mg, Zydus Lifesciences said in a regulatory filing.nnnRead more at:nhttps://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-lifesciences-gets-usfda-nod-for-generic-acne-treating-drug/articleshow/101107316.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
Zydus' Generic Minocycline Hydrochloride Receives Approval in the U.S.
Clinical trial achieved all three primary objectives and subjects completed 16-week treatment with no significant safety issues Results indicate that DFD-29 can be safely used for up to 16 weeks with...
Nexus's Generic Minocycline Hydrochloride Receives Approval in the U.S.
LAVAL, Quebec, May 18, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its oral health care business, OraPharma, today announced the publication of a new study, which showed that ARESTIN® (minocycline HCI) microspheres, 1mg decreased certain pathogenic burdens, also known as infection burdens, in adults with periodontitis when applied immediately after scaling and root planning (SRP) and again at a three-month reapplication, versus SRP alone. ARESTIN is an FDA-approved antibiotic applied locally to gum pockets in adults with periodontitis following an SRP procedure and is used as part of an overall oral health program. ARESTIN should not be used in people who are allergic to minocycline or tetracyclines.
Journey Medical has completed participant enrolment and randomisation in its Phase III clinical trials programme of DFD-29 (minocycline modified release capsules 40mg) to treat papulopustular rosacea (PPR).
Journey Medical Corporation Completes Enrollment in Phase 3 Clinical Trials Evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for the Treatment of Papulopustular Rosacea
Sidmak's Generic Minocycline Hydrochloride Receives Approval in the U.S.
SCOTTSDALE, Ariz., Aug. 30, 2022 (GLOBE NEWSWIRE) -- Journey Medical Corporation (NASDAQ: DERM) (“Journey Medical”), a commercial-stage biopharmaceutical company that focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions, today announced that it has enrolled and randomized over 50 percent of the patients in its Phase 3 clinical program to assess the safety, efficacy and tolerability of DFD-29 (Minocycline Modified Release Capsules 40 mg) for the treatment of papulopustular rosacea. The Phase 3 clinical trials are part of a collaboration with Dr. Reddy’s Laboratories Ltd. for the ongoing development and commercialization of the DFD-29 program.