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New Drug Application


Exciting news was disseminated from Avanir Pharmaceuticals’ on March 28, 2014 with their announcement that the FDA had accepted a New Drug Application for their intranasal form of Sumatriptan. Designed as a novel and investigational drug-device combination product coined AVP-825, this unique form of Sumatriptan is a breath powered, intranasal form of migraine treatment. The[…]

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The culmination of the month of January 2014 brought good news for Medac Pharma regarding their innovative Methotrexate autopen. This easy to use, novel, self-injectable device was accepted as a New Drug Application (NDA) by the FDA. As a subcutaneous injectable form of Methotrexate, the autopen is a ready to use device geared for patients[…]

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On January 24, 2014 the U.S. Food & Drug Administration {FDA} announced their approval for an abbreviated new drug application for anti-diabetic Repaglinide tablets. The generic formulation of the Prandin tablets, in both one and two milligram strengths will be produced by Perrigo. The advent of the abbreviated new drug application for Repaglinide is sure[…]

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On April 3, 2013 the FDA approved the new drug application carbinoxamine maleate, CAS number 3505-38-2, for the treatment of allergic rhinitis. Targeted for patients suffering from seasonal and perennial allergic rhinitis, the approval of carbinoxamine is a novel approach to allergy relief. Carbinoxamine is the first sustained-release histamine receptor blocking agent that is indicated[…]

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As a treatment for Type 2 diabetes lixisenatide is approved by the EU and currently under review as a New Drug Application {NDA} by the FDA. Sanofi is preparing to launch lixisenatide in the European Union as in the latter of first quarter 2013, with the proprietary name Lyxumia. What makes lixisenatide unique is not[…]

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