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Medac Pharma Has Reported FDA Acceptance of a NDA for Its Lead Product Candidate
Feb 7, 2014US-based Medac Pharma has reported the US Food and Drug Administration (FDA) acceptance of a new drug application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection ...
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The US FDA Has Approved Antares Pharma's OTREXUP
Oct 16, 2013The US Food and Drug Administration (FDA) has approved Antares Pharma's (Antares) OTREXUP, a single-dose, disposable auto-injector for the subcutaneous (SC) once-weekly administration of methotrexate (MTX). OTREXUP is reportedly the first ...
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Tofacitinib Has Obtained Approval in Several Additional Countries Globally
Jul 17, 2013Pfizer's rheumatoid arthritis treatment, tofacitinib, has obtained approval in several additional countries globally, including Switzerland, Argentina, Kuwait, UAE and Russia for patients with inadequate response to current therapies. The ...
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The USFDA Has Accepted Pfizer's Supplemental New Drug Application
Jun 25, 2013The USFDA has accepted Pfizer's supplemental new drug application (sNDA) to expand labeling of rheumatoid arthritis medication Xeljanz (tofacitinib citrate) to include inhibition of structural damage progression. The data from ORAL Start ...
Tags: FDA, Pfizer sNDA, Xeljanz Labeling
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The European Medicines Agency Cleared Roche's RoACTEMRA for The Treatment of Arthritis
Jun 13, 2013The European Medicines Agency has cleared Roche's RoACTEMRA for the treatment of a rare form of arthritis, polyarticular juvenile idiopathic arthritis (PJIA), in children aged two years and above. Approved for use alone or in combination ...
Tags: Arthritis Drug, Medicine
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Sanofi and Regeneron Pharmaceuticals Have Announced The Commencement of Patient Enrollment
May 21, 2013Sanofi and Regeneron Pharmaceuticals have announced the commencement of patient enrollment in two Phase 3 rheumatoid arthritis (RA) trials, the COMPARE and ASCERTAIN trials, with Sarilumab. The first fully human monoclonal antibody ...
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FDA Has Accepted to Review Antares Pharma's New Drug Application
Feb 28, 2013The US Food and Drug Administration (FDA) has accepted to review Antares Pharma's new drug application (NDA) of OTREXUP, designed for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis. OTREXUP ...
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Antares Pharma Has Submitted a NDA to The USFDA for Otrexup
Dec 19, 2012Antares Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Otrexup, a combination product to deliver methotrexate methotrexate (MTX) using Medi-Jet technology. Antares Pharma president ...
Tags: NDA, FDA, medical technology
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