Aurobindo Pharma`s Generic Mycophenolate Mofetil Receives Approval in the U.S.
Enforcement Report - Week of November 15, 2023
Strides Pharma Science Ltd on Wednesday said its wholly-owned arm, Strides Pharma Global Pte. Ltd, Singapore, has received approval from the US health regulator for generic Mycophenolate Mofetil for oral suspension indicated in organ transplant patients to avoid rejection. The approval granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regu .
Amneal Pharma's Generic Mycophenolate Mofetil Receives Approvals in US
Lannett Company, Inc. announced that it has commenced marketing mycophenolate mofetil for oral suspension USP, 200 mg/mL, an internally developed product.
Lannett Co Inc`s Generic Mycophenolate Mofetil Receives Tentative Approval In US
In 2017, the FDA greenlighted Flexion Therapeutics‘ intra-articular therapy, Zilretta, designed as a treatment for osteoarthritis-related knee pain. Now, two years later, the company has announced that the FDA needs additional time to complete the review of its supplemental NDA for Zilretta.
Methotrexate and the more expensive mycophenolate mofetil performed similarly in a head-to-head clinical trial that compared the two drugs for treating noninfectious uveitis, an eye disease that accounts for up to 15% of blindness in the US. In cases of more severe disease, posterior uveitis and panuveitis, the international trial showed that methotrexate was more effective in controlling inflammation. Investigators published results from the trial in the Journal of the American Medical Association. The National Eye Institute, part of the National Institutes of Health, funded the trial.
Enforcement Report - Week of May 15, 2019
Par Pharmaceutical recalls Mycophenolate Mofetil Injection, USP