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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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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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Apixaban, CAS number 503612-47-3, is showing itself to be a viable option for patients with atrial fibrillation who are in need of an anticoagulant. In two studies, ARISTOTLE and AVERROES, which included over 24,000 patients, Apixaban (Eliquis) showed statistically significant superiority to Warfarin.  A 21%  lower stroke risk for patients with atrial fibrillation was an[…]

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Pfizer is currently conducting clinical trials for the drug Tofacitinib CAS# 540737-29-9, as a non injectable treatment for Rheumatiod Arthritis, as well as Psoriasis. Tofacitinib is also being investigated as potential treatment for inflammatory bowel disease, a preventative for organ transplant rejection, and other immunological diseases. Both five and ten milligram doses are slated to[…]

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