Tag: US Food and Drug Administration

Zydus Cadila gets FDA’s final approval for Vortioxetine Tablets

businessnewstoday- September 19, 2021 0

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 ... Read More

Aurobindo subsidiary Eugia gets FDA approval for Cyclophosphamide Injection

businessnewstoday- August 28, 2021 0

Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug Administration (FDA) for the new drug application ... Read More

Zydus Cadila gets FDA approval for Revlimid generic Lenalidomide Capsules

businessnewstoday- August 22, 2021 0

Zydus Cadila said that the US Food and Drug Administration (FDA) has granted it tentative approval for Lenalidomide Capsules, a generic version of Celgene Corporation’s ... Read More

Lupin gets tentative FDA approval for Brivaracetam Tablets

businessnewstoday- August 16, 2021 0

Lupin Limited said that it has been granted tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) ... Read More

Zydus Cadila gets FDA approval for Mesalamine Extended-Release Capsules

businessnewstoday- August 16, 2021 0

Zydus Cadila said that it has secured final approval from the US Food and Drug Administration (FDA) to market Mesalamine Extended-Release Capsules in the strength ... Read More

Vivet’s VTX-801 gene therapy gets FDA fast track status in Wilson Disease

businessnewstoday- August 14, 2021 0

Vivet Therapeutics, a biotech company backed by Pfizer, has been given fast track designation by the US Food and Drug Administration for its gene therapy ... Read More

Cipla gets FDA approval for generic version of Novartis’ Durezo

businessnewstoday- August 12, 2021 0

Cipla Limited said that it has secured final approval for its abbreviated new drug application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05% from the US Food ... Read More

Lantern Pharma bags FDA orphan drug status for LP-184 in pancreatic cancer

businessnewstoday- August 11, 2021 0

Lantern Pharma has secured orphan drug designation for its small molecule drug candidate LP-184 from the US Food and Drug Administration (FDA) for the treatment ... Read More

Octapharma gets Octagam 10% FDA approval for adult dermatomyositis

businessnewstoday- July 20, 2021 0

Octapharma USA has secured approval for Octagam 10% from the US Food and Drug Administration (FDA) for the treatment of adult dermatomyositis. The company, which ... Read More

Unichem Laboratories gets FDA approval for Sitagliptin Tablets

businessnewstoday- July 10, 2021 0

Unichem Laboratories Limited said that it has secured tentative approval for abbreviated new drug application (ANDA) of Sitagliptin Tablets USP, 25 mg, 50 mg, and ... Read More