Latest News - FDA Approval/Clearance

Thursday, April 19, 2012

FDA Seeks More Information on Pliaglis

FDA's Complete Response Letter to Galderma Laboratories LP outlines additional information the FDA requires before it will approve the sNDA for Pliaglis, developer Nuvo Research, Inc. reports. The res…

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Monday, March 12, 2012

Cellceutix Files pre-IND Submission for Prurisol for Psoriasis

Cellceutix Corporation (OTCBB: CTIX) filed a pre-IND submission with the FDA for Prurisol (also termed KM-133), a drug in development for treatment of psoriasis. The company is seeking guidance to att…

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Thursday, March 08, 2012

FDA Approves Differin Pump

FDA approved a new pump dispenser for Galderma's Differin Gel 0.3% (adapalene). The new pump dispenser will be available in pharmacies by prescription in the second quarter. According to results of a…

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Wednesday, February 29, 2012

FDA Approves Methoxsalen USP Provider

FDA has approved a secondary supplier of Methoxsalen USP, prescribed under the brand name Oxsoralen-Ultra┬« (methoxsalen) Capsules, USP, 10mg. Valeant Dermatology, a division of Valeant Pharmaceuti…

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