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[…]
FDA Accepts NDA for Novel Intranasal Sumatriptan to Treat Migraines
Anti-Migraine, Drug Research & Development API Tags: migraine headachesmigrainesNew Drug Application Apr 24, 2014
FDA Accepts of NDA for Autopen Containing Methotrexate
Anti-Psoriatic, Drug Research & Development API, Immunosuppressant, NDA Tags: MethotrexateNDANew Drug Application Feb 20, 2014
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[…]
Repaglinide Receives Abbreviated New Drug Application
Anti-Diabetic, Drug Research & Development API, NDA Tags: New Drug Applicationtype 2 Diabetestype 2 diabetes mellitus Jan 27, 2014
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[…]
FDA Approves New Drug Application for Carbinoxamine
Analgesic, Anti-Inflammatory Tags: allergic conjunctivitisasthmaNew Drug Application Apr 11, 2013
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[…]
Lixisenatide Approved By the EU and Being Reviewed By the FDA
Anti-Diabetic, Drug Research & Development API, EU Approved 2013, NDA Tags: HbA1cNew Drug Applicationtype 2 Diabetes Feb 27, 2013
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[…]
