Johnson & Johnson (NYSE: JNJ) is seeking U.S. Food and Drug Administration (FDA) approval for SPRAVATO (esketamine) as a standalone treatment for adults with treatment-resistant depression (TRD). This application marks a significant milestone in the treatment of major depressive disorder (MDD). The American pharma major has submitted a supplemental New Drug Application (sNDA) to the […]
Strides Pharma Science Limited (Strides) has made a notable advancement in the field of mental health treatment by securing approval from the United States Food & Drug Administration (USFDA) for its Fluoxetine Tablets 10 mg and 20 mg. This development is significant for Strides’ subsidiary, Strides Pharma Global Pte. Limited, Singapore, positioning the company as […]
In a notable development for the pharmaceutical industry, Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has received final approval from the United States Food and Drug Administration (USFDA) for the manufacture and market of Chlorpromazine Hydrochloride Injection USP. The approval encompasses two formulations: 25 mg/mL and 50 mg/2 mL (25 mg/mL) in Single-Dose […]