CAMBRIDGE, Mass. and CHICAGO, Dec. 19, 2023 /PRNewswire/ -- Shorla Oncology ('Shorla'), a U.S.-Ireland specialty pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults. JYLAMVO has been shown to have a sweet, palatable taste1,2*and is approved to treat adults with acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen; mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen; relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen; rheumatoid arthritis; and severe psoriasis.
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Enforcement Report - Week of November 1, 2023
Daito's Generic Methotrexate Sodium Receives Approval in US
The National Comprehensive Cancer Network (NCCN) has announced a guideline update concerning the treatment of patients with acute lymphoblastic leukemia (ALL), B-cell lymphomas, pediatric ALL, and pediatric aggressive mature B-cell lymphoma.1
DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced the publication of the long-term data from the MIRROR randomized controlled clinical trial of KRYSTEXXA® (pegloticase) injection with methotrexate, a commonly used immunomodulator, in ACR Open Rheumatology [https://doi.org/10.1002/acr2.11578].
LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced positive top-line results from the Phase 2 clinical trial of intravitreal ADX-2191 (methotrexate injection, USP), an investigational drug candidate, in patients with retinitis pigmentosa. Relative to baseline, the clinical trial demonstrated statistically significant improvement in retinal function across a number of different physiological and psychophysical assessments.
LEXINGTON, Mass.--(BUSINESS WIRE)--(Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL). Although no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there was a “lack of substantial evidence of effectiveness” due to “a lack of adequate and well-controlled investigations” in the literature-based NDA submission. Based on prior discussions with the FDA, Aldeyra did not conduct any clinical trials of ADX-2191 in PVRL.
June 9 (Reuters) - The U.S. Food and Drug Administration said on Friday it is seeking new suppliers to ease shortages of methotrexate, one of the most commonly used cancer drugs, building on its push to shore up two other scarce chemotherapy medicines.
Intas Pharmaceuticals Limited on FDA Import Alert List