Granules India arm bags USFDA nod for Acetaminophen and Ibuprofen Tablets Ruchika Sharma14 July 2023 11:09 AM ISTAcetaminophen and Ibuprofen Tablets are used for temporary relief for minor aches and pains due to: headache, toothache, backache, menstrual cramps,...
USFDA issues two observations for Lupin Nagpur facility Ruchika Sharma13 July 2023 1:04 PM ISTMumbai: Lupin has announced the United States Food and Drug Administration (USFDA) has concluded the inspection at the...
Dr Reddy's Labs proposed rituximab biosimilar application accepted for review by USFDA, EMA and MHRA Ruchika Sharma13 July 2023 12:02 PM ISTDRL_RI is being developed as a biosimilar of Rituxan / MabThera (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody.
Aurobindo Pharma arm bags USFDA nod for Sevelamer Hydrochloride Tablets Ruchika Sharma13 July 2023 11:03 AM ISTSevelamer Hydrochloride Tablets 400 mg and 800 mg is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on...
JnJ electrosurgical tools recall classified as most serious by USFDA Ruchika Sharma12 July 2023 2:30 PM ISTJ&J MedTech said during the investigation into burn injuries related to use of the devices, it was determined that in some instances the products were...
Marksans Pharma bags USFDA nod for Acetaminophen, Ibuprofen Tablets Ruchika Sharma12 July 2023 12:31 PM ISTThe pivotal approval, Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg provides relief for multiple pain-related symptoms by combining two powerful...
Lupin Pithampur Unit-2 facility gets EIR from USFDA Ruchika Sharma12 July 2023 11:15 AM ISTMumbai: Global pharma major Lupin Limited has announced that the company has received the Establishment Inspection Report (EIR) from the United States...
Zydus Lifesciences concludes USFDA inspection at Ahmedabad facility with nil observations Ruchika Sharma8 July 2023 10:32 AM ISTAhmedabad: Pharma major, Zydus Lifesciences Ltd., has announced that the group’s manufacturing facility at SEZ-2 located at Pharmez, Ahmedabad,...
USFDA grants traditional approval for Eisai Leqembi for Alzheimer's disease treatment Ruchika Sharma7 July 2023 1:30 PM ISTStockholm:BioArctic AB's (publ)partner Eisai has announced that the U.S. Food and Drug Administration, FDA, has approved the supplemental Biologics...
USFDA rejects Amneal Pharma Parkinson's drug over safety concerns Ruchika Sharma6 July 2023 4:30 PM ISTThe agency has not identified efficacy or manufacturing issues with the treatment.
Abbott gets USFDA nod for dual chamber leadless pacemaker Ruchika Sharma6 July 2023 3:30 PM ISTAVEIR DR leadless pacing system is made up of two devices - the previously-approved AVEIR VR single chamber device, which paces the right ventricle,...
Lupin Dolutegravir Tablets for Oral Suspension gets tentative USFDA nod for HIV/AIDS Ruchika Sharma4 July 2023 5:38 PM ISTMumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration...
