Browsing Tag
US Food and Drug Administration
348 posts
Zydus Cadila gets FDA’s final approval for Vortioxetine Tablets
Zydus Cadila has secured final approval from the US Food and Drug Administration (FDA) to market Vortioxetine Tablets…
Aurobindo subsidiary Eugia gets FDA approval for Cyclophosphamide Injection
Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug…
Zydus Cadila gets FDA approval for Revlimid generic Lenalidomide Capsules
Zydus Cadila said that the US Food and Drug Administration (FDA) has granted it tentative approval for Lenalidomide…
Lupin gets tentative FDA approval for Brivaracetam Tablets
Lupin Limited said that it has been granted tentative approval from the US Food and Drug Administration (FDA)…
Zydus Cadila secures US FDA approval for Mesalamine Extended-Release Capsules for ulcerative colitis remission maintenance
Zydus Cadila gets US FDA approval for Mesalamine Extended-Release Capsules 0.375g to maintain ulcerative colitis remission, strengthening its US generics portfolio.
Vivet’s VTX-801 gene therapy gets FDA fast track status in Wilson Disease
Vivet Therapeutics, a biotech company backed by Pfizer, has been given fast track designation by the US Food…
Cipla gets FDA approval for generic version of Novartis’ Durezo
Cipla Limited said that it has secured final approval for its abbreviated new drug application (ANDA) for Difluprednate…
Lantern Pharma bags FDA orphan drug status for LP-184 in pancreatic cancer
Lantern Pharma has secured orphan drug designation for its small molecule drug candidate LP-184 from the US Food…
Octapharma gets Octagam 10% FDA approval for adult dermatomyositis
Octapharma USA has secured approval for Octagam 10% [Immune Globulin Intravenous (Human)] from the US Food and Drug…
Unichem Laboratories gets FDA approval for Sitagliptin Tablets
Unichem Laboratories Limited said that it has secured tentative approval for abbreviated new drug application (ANDA) of Sitagliptin…