Depression is a pervasive psychiatric condition recognized as a leading cause of disability worldwide. It spans a spectrum from mild depressive symptoms to severe cases accompanied by hallucinations and delusions, significantly impacting quality of life and increasing the risk of premature death from various causes. Symptoms of Depression Depression manifests through both emotional and biological […]
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) approved ZURZUVAE (zuranolone) 50 mg for adults with postpartum depression (PPD). The treatment is the first of its kind, offering an oral, once-daily, 14-day course that can provide rapid improvements in depressive symptoms for women with postpartum […]
Lupin Inc., a wholly-owned subsidiary of the global pharmaceutical major Lupin Limited, announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP in various strengths. The approval permits the New Jersey-based company to market a generic equivalent to […]
Zydus Lifesciences said that it has secured final approval for Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10mg, 15 mg, and 20 mg from the US Food and Drug Administration (FDA). The approval gives the Indian pharma company to manufacture and market the generic version of Zyprexa Zydis Orally Disintegrating Tablets. Olanzapine Orally Disintegrating Tablets […]
Dr. Reddy’s Laboratories said that it has launched Venlafaxine ER Tablets, which is therapeutically equivalent to Osmotica Pharmaceutical US’ Venlafaxine Extended-Release Tablets, 150 mg and 225 mg. Approved by the US Food and Drug Administration (FDA), Venlafaxine is indicated for the treatment of depression. According to IQVIA Health, the brand and generic had sales of […]
Zydus Cadila has secured final approval from the US Food and Drug Administration (FDA) to market Vortioxetine Tablets in the strengths of 5mg, 10mg, 20mg for the treatment of depression. The reference listed drug (RLD) of Vortioxetine Tablets is Trintellix Tablets in the US. Vortioxetine is a selective serotonin reuptake inhibitor (SSRI) and serotonin receptor […]
Unichem Laboratories, an Indian specialty pharma company, said that it has secured abbreviated new drug application (ANDA) approval for its Amitriptyline HCl Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the US Food and Drug Administration (FDA). Amitriptyline HCl Tablets are a generic version of ELAVIL (Amitriptyline […]
Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Lurasidone Hydrochloride Tablets is a generic version of Latuda Tablets owned by Sunovion Pharmaceuticals, which has approval as monotherapy […]
Wisconsin-based Usona Institute has been granted breakthrough therapy designation for psilocybin from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). According to Usona Institute, the designation secured by psilocybin for major depressive disorder acknowledges the unmet medical need in the broad population and also the potential for significant […]
CNS biopharma company Sage Therapeutics is all set to commercially launch its ZULRESSO (brexanolone) injection in the US later this month for the treatment of postpartum depression (PPD), a major depressive episode that can occur during pregnancy or after delivery. Sage Therapeutics said that the US Drug Enforcement Administration (DEA) has put ZULRESSO into Schedule […]