FDA Accepts of NDA for Autopen Containing Methotrexate

FDA Accepts of NDA for Autopen Containing Methotrexate

MethotrexateThe 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 with rheumatoid arthritis, psoriasis and poly-articular-course juvenile rheumatoid arthritis. In addition to the convenience of a simple injectable treatment that patients with debilitating conditions like rheumatoid arthritis can utilize with ease, the Methotrexate autopen can be customized for dose specific drug volumes. The painful and incurable symptoms of autoimmune diseases like rheumatoid arthritis, poly-articular-course juvenile rheumatoid arthritis and psoriasis require a lifetime of treatment for the vast majority of patients. By utilizing a handy autopen with customizable dosages of Methotrexate the patients suffering from these inflammatory autoimmune conditions have the opportunity for increased mobility, convenient administration and personalized dosing.

Methotrexate works effectively by reducing the inflammation associated with rheumatoid arthritis and slowing the progression of the disease. As a disease-modifying antirheumatic drug Methotrexate is also considered to be an immunosuppressive medication. Methotrexate is one of the most commonly used treatments for rheumatoid arthritis, as adverse effects from this this drug are few. Statistics show that over half of the patients who are administered Methotrexate to treat their symptoms of rheumatoid arthritis continue to take this medication faithfully for at least three consecutive years. This data indicates that this is the longest time for patient medication adherence when compared to other best in care medications for RA. The advent of the autopen will only increase the number of patients adhering to their medication schedule, and reaping the benefits of this formidable drug.

LGM Pharma provides Methotrexate CAS# 59-05-2, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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