Lupin recalls 16,056 bottles of tuberculosis drug Rifampin in US Ruchika Sharma21 Jan 2023 2:49 PM ISTThe affected lot has been produced at Lupin's Aurangabad plant and marketed in the US by Baltimore-based Lupin Pharmaceuticals.
USFDA rejects accelerated approval for Eli Lilly Alzheimer's drug Donanemab Ruchika Sharma20 Jan 2023 1:30 PM IST"I don't think it says anything negative about the drug. It was just a manifestation of the study design," said Dr. Ronald Petersen, an Alzheimer's...
Alembic Pharma bags USFDA nod for mantle cell lymphoma drug Acalabrutinib Ruchika Sharma19 Jan 2023 3:15 PM ISTAcalabrutinib Capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy...
Aurobindo Pharma arm gets 2 USFDA observations for Unit I, III in Telangana Ruchika Sharma19 Jan 2023 10:56 AM ISTHyderabad: Aurobindo Pharma has announced that the US Food and Drug Administration (USFDA) has issued Form 483 with 2 observations at the end of the...
Abbott gets USFDA nod for next-generation TAVI system Navitor to treat Aortic Stenosis Ruchika Sharma18 Jan 2023 3:30 PM ISTNavitor features a unique fabric cuff (NaviSeal) to reduce or eliminate the backflow of blood around the valve frame known as paravalvular leak (PVL).
Strides Pharma Science biologics arm gets USFDA EIR for Bengaluru facility Ruchika Sharma18 Jan 2023 12:18 PM ISTBengaluru: Stelis Biopharma Limited, an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm...
USFDA approves label update for Rybelsus allowing use as first-line option for adults with type 2 diabetes: Novo Nordisk Ruchika Sharma16 Jan 2023 4:15 PM ISTPlainsboro: Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Rybelsus (semaglutide) tablets...
Lupin bags USFDA nod for Dolutegravir, Rilpivirine tablets to treat HIV infection Ruchika Sharma16 Jan 2023 3:20 PM ISTMumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration...
USFDA issues 3 observations for Granules India Gagillapur facility Ruchika Sharma16 Jan 2023 2:30 PM ISTHyderabad: Granules India has recently announced that US Food and Drug Administration (USFDA) has concluded Pre-Approval Inspection (PAI) with three...
Lupin gets 2 USFDA observations for Somerset facility Ruchika Sharma16 Jan 2023 1:15 PM ISTMumbai: Lupin has announced that the company has received two observations from the US Food and Drug Administration (USFDA) at the closure of...
Zydus Lifesciences arm bags USFDA approval for schizophrenia drug Brexpiprazole Ruchika Sharma14 Jan 2023 11:13 AM ISTThe drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
USFDA inspection: Piramal Pharma gets Form 483 with 6 observations for Lexington facility Ruchika Sharma12 Jan 2023 11:32 AM ISTThe observations were classified under VAI (Voluntary Action Indicated) and does not relate to data integrity.
