Baxter International issues urgent correction for certain software versions of infusion pumps Ruchika Sharma1 Aug 2023 3:30 PM ISTThe false alarm may lead to an interruption or delay of therapy, and Baxter has received three reports of serious injury potentially associated with...
Aurobindo Pharma bags USFDA nod for Saxagliptin Tablets Ruchika Sharma1 Aug 2023 2:45 PM ISTSaxagliptin Tablets, 2.5 mg and 5 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes...
Janssen seeks USFDA nod for expanded pediatric indication for HIV-1 therapy Edurant Ruchika Sharma1 Aug 2023 12:32 PM ISTTitusville: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA)...
GSK gets USFDA nod for Jemperli plus chemotherapy for dMMR/MSI-H primary advanced or recurrent endometrial cancer Ruchika Sharma1 Aug 2023 11:30 AM ISTJemperli is already approved in the US as monotherapy in adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or...
Alembic Pharma, Sun Pharma recall drugs in US over manufacturing issues Ruchika Sharma31 July 2023 12:30 PM ISTThe US Health regulator stated that Alembic Pharmaceuticals is recalling 2,844 units of Diclofenac Sodium Topical Solution in the American market.
FDA approves OTC naloxone nasal spray product for opioid overdose Dr. Kamal Kant Kohli31 July 2023 11:45 AM ISTUSA: RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), has received approval from the U.S. Food and Drug...
USFDA concludes inspection at Gland Pharma Visakhapatnam facility with zero 483 observations Ruchika Sharma31 July 2023 11:27 AM ISTTelangana: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has conducted Good Manufacturing Practice...
Lupin announces resolution of USFDA warning letter for Goa, Pithampur facilities Ruchika Sharma28 July 2023 12:08 PM ISTMumbai: Global pharma major Lupin Limited has announced that it has received correspondence from the US FDA that it has now addressed the concerns...
Zydus Lifesciences bags USFDA nod for Plerixafor Injection Ruchika Sharma27 July 2023 3:25 PM ISTAhmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug...
USFDA accepts application for Boehringer Ingelheim OFEV for children, adolescents aged 6-17 years old with fibrosing interstitial lung disease Ruchika Sharma27 July 2023 1:30 PM ISTRidgefield: Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application...
Natco Pharma seeks USFDA nod for generic Erdafitinib Tablets Ruchika Sharma27 July 2023 11:41 AM ISTHyderabad: NATCO Pharma Limited has announced the submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification...
Aurobindo Pharma arm Telangana facility concludes USFDA inspection with zero observations Ruchika Sharma26 July 2023 2:38 PM ISTHyderabad: Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has closed the inspection with zero...
