Lupin launches generic equivalent of Vivlodex Capsules Ruchika Sharma29 Dec 2020 11:16 AM ISTThe product is indicated for management of osteoarthritis (OA) pain.
USFDA informs Biocon Biologics, Mylan about biosimilar Avastin deferred action Ruchika Sharma26 Dec 2020 11:52 AM ISTNew Delhi: Biotechnology major Biocon on Friday said its arm, Biocon Biologics, and Mylan have been informed by the US health regulator of a deferred...
Lupin gets USFDA nod for generic equivalent of Jublia Topical Solution Ruchika Sharma26 Dec 2020 11:26 AM ISTEfinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and...
Caplin Steriles bags USFDA nod for Etomidate injection Ruchika Sharma24 Dec 2020 2:18 PM ISTEtomidate is a general anesthetic, used for the induction of general anesthesia and for the supplementation of subpotent anesthetic agents.
Novartis inclisiran gets complete USFDA response letter for treating hyperlipidemia Ruchika Sharma21 Dec 2020 1:01 PM ISTThe FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act(PDUFA) action date of December 23, 2020, due to unresolved...
Glenmark Pharma gets USFDA nod for Dabigatran Etexilate Capsules Ruchika Sharma21 Dec 2020 12:39 PM ISTMumbai: Drugmaker, Glenmark Pharmaceuticals Ltd, today announced that the company has received tentative approval by the United States Food &...
Lupin gets USFDA nod for generic equivalent of Welchol Tablets Ruchika Sharma19 Dec 2020 11:30 AM ISTMumbai, Baltimore: Pharma major, Lupin Limited, has recently announced that the company has received approval for its Colesevelam Hydrochloride...
Strides Pharma secures USFDA okay for Oxybutynin Chloride Tablets Ruchika Sharma19 Dec 2020 10:30 AM ISTThe medication is used to treat overactive bladder and urinary conditions.
Cipla associate Avenue Therapeutics gets regulatory update for intravenous tramadol Farhat Nasim18 Dec 2020 6:23 PM ISTCipla said Avenue had requested this Type A meeting to address a CRL it received from the US health regulator regarding the New Drug Application (NDA)...
Moderna COVID vaccine likely to get USFDA emergency nod soon MD Bureau18 Dec 2020 12:45 PM ISTNew York: After an eight hour debate, a high powered vaccine advisory panel overwhelmingly endorsed Moderna's Covid-19 vaccine for emergency use...
Extra doses from vials of Pfizer COVID-19 vaccine can be used: USFDA Ruchika Sharma17 Dec 2020 1:15 PM ISTThe Pfizer vials are supposed to hold five doses, according to the labeling, but media reports said pharmacists had found a way for a sixth or even a...
Moderna Covid-19 vaccine nears regulatory authorization, clears first USFDA hurdle Ruchika Sharma16 Dec 2020 12:14 PM ISTNew Delhi: Moderna Inc's Covid-19 vaccine appeared to be set for regulatory authorization this week after U.S. Food and Drug Administration staff...
