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NDA


The USFDA has received the Aripiprazole Lauroxil NDA, submitted by Ireland-based Alkermes for treating patients with schizophrenia. Alkermes shares gained almost 2.3% on the news. Aripiprazole lauroxil is a partial dopamine agonist of the second generation class of antipsychotics, with one-month and two-month formulations, developed for the treatment of the mental disorder schizophrenia, which is[…]

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Recently revealed results from a successful Phase 3 study combining Ivacaftor {Kalydeco} and Lumacaftor {VX-809} are extremely positive for patients with a common Cystic Fibrosis {CF} mutation. Patients who have the mutation of Cystic Fibrosis, which entails two copies of the F508del, have demonstrated in Phase 3 clinical trials an effective response to treatment with[…]

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Idelalisib has captured the attention of pharmaceutical research and development teams with the latest data touting its targeted treatment for both unresectable non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The FDA accepted Gilead Sciences’ new drug application early in 2014 for the treatment of refractory indolent NHL, and the target review date for the[…]

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Alkermes excitedly announced extremely positive study data from a Phase 3 trial of Aripiprazole. This randomized, placebo-controlled and double-blind study gleaned better than expected results, leading pharmaceutical executives at Alkermes to set a plan in motion for an NDA by the third quarter of 2014. As a long acting and injectable antipsychotic treatment Aripiprazole Lauroxil[…]

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Recently, the Trelagliptin Succinate NDA has captured pharmaceutical headlines as it was accepted by the Japanese Ministry of Health, Labour and Welfare. As a unique once weekly treatment for type 2 diabetes, Trelagliptin Succinate is an effectual dipeptidyl peptidase-IV inhibitor. As one of the few providers in the world of Trelagliptin Succinate, LGM Pharma offers[…]

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BioCryst Pharmaceuticals recently announced that the Peramivir NDA has been accepted for review by the FDA. The exciting news about the antiviral comes on the heels of a deadly flu season around the world, with the H1N1 virus being most commonly found. Widespread flu activity around the United States has caused alarm for practitioners and patients who[…]

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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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Fluticasone Propionate, which is currently short in supply, received a New Drug Application, or NDA at on July 31, 2013. Drug maker Perrigo announced the new drug application for fluticasone propionate lotion, 0.05%. This form of fluticasone propionate lotion is the generic equivalent to Cutivate Lotion, 0.05%. The use of the effectual and tolerable corticosteroid[…]

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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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