Zydus Lifesciences recalls over 55000 bottles of gout drug Colchicine in US Ruchika Sharma27 March 2023 12:15 PM ISTThe affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc.
USFDA okays Lupin Valbenazine Capsules to treat Dyskinesia Ruchika Sharma27 March 2023 11:21 AM ISTMumbai: Pharma major, Lupin Limited, today announced that the company has received tentative approval from the United States Food and Drug...
USFDA inspection: Alembic Pharma gets 2 observations for Karkhadi facility Ruchika Sharma25 March 2023 11:15 AM ISTVadodara: Drugmaker, Alembic Pharmaceuticals, has announced that the US Food and Drug Administration (USFDA) has issued a Form 483 with two minor...
Zydus Lifesciences wins USFDA approval for Lubiprostone Capsules to treat constipation Ruchika Sharma24 March 2023 3:00 PM ISTThe drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, India.
Lupin gets USFDA nod for primary biliary cholangitis drug Obeticholic Acid Ruchika Sharma24 March 2023 2:00 PM ISTMumbai: Global pharma major, Lupin Limited, has announced that the company has received tentative approval from the United States Food and Drug...
Zydus Lifesciences Depression drug Doxepin Hydrochloride bags USFDA okay Ruchika Sharma24 March 2023 11:24 AM ISTThe drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad, India.
USFDA refuses to approve AbbVie Parkinson's disease therapy ABBV-951, seeks more information Ruchika Sharma23 March 2023 12:15 PM ISTThe US health regulator has not sought additional efficacy and safety trials, the company said, adding it plans to resubmit the marketing application...
Regeneron Pharma bags USFDA nod for Evkeeza for young children with ultra-rare form of cholesterol Ruchika Sharma23 March 2023 10:00 AM ISTHomozygous familial hypercholesterolemia occurs when two copies of the FH-causing genes are inherited, one from each parent, resulting in dangerously...
USFDA nod to citrate free high concentration formulation of biosimilar Hyrimoz injection: Sandoz Ruchika Sharma22 March 2023 1:45 PM ISTSandoz intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023.
Lupin gets USFDA approval for generic equivalent of Rexulti Tablets Ruchika Sharma22 March 2023 11:45 AM ISTThis product would be manufactured at Lupin's Pithampur facility in India.
Zydus Lifesciences arm bags USFDA nod for ulcerative colitis drug Tofacitinib Ruchika Sharma22 March 2023 10:00 AM ISTTofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and for the treatment of adult...
Glenmark Pharma gets final USFDA nod for Schizophrenia drug Prochlorperazine Maleate Ruchika Sharma21 March 2023 4:00 PM ISTMumbai: Glenmark Pharmaceuticals Ltd. has announced that the company has received final approval from the United States Food & Drug Administration...
