Situated between the NDA and the ANDA is an increasingly popular drug commercialization pathway – the 505(b)(2) – and it potentially offers pharmaceutical companies clear advantages. We’ve been working with clients for years on 505(b)(2) drugs. At present, we are working on well over 100 API projects using the 505(b)(2) pathway. But why is there[…]
Understanding 505(b)(2) Drug Development & API Supply Issues
LGM Pharma Tags: 505b1505b2505jANDANDA Nov 04, 2019
Aripiprazole Lauroxil NDA Submitted to Treat Schizophrenia
Antipsychotic, Drug Research & Development API, NDA, OTC and Compounding Product Tags: antipsychoticIdelalisibNDA Sep 02, 2014
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[…]
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[…]
Is Apixaban the Next New Anticoagulant?
Antithrombotic, Drug Research & Development API Tags: anticoagulantatrial fibrillationNDAWarfarin Feb 03, 2012
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[…]
Tofacitinib as a Non Injectable Treatment for Rheumatoid Arthritis
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, Immunosuppressant Tags: HumiraNDAPfizerPsoriasis Jan 09, 2012
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[…]
