GSK gets USFDA nod for HIV-1 drug branded as Dovato Farhat Nasim9 April 2019 3:50 AM GMTGSK already has two-drug regimen Juluca on the market, but only for the smaller market of HIV patients that have received prior treatment. Dovato is...
Lupin, Aurobindo Pharma recalls multiple lots of BP drug including VALSARTAN Farhat Nasim1 April 2019 4:20 AM GMTAurobindo Pharma is also recalling certain lots of Amlodipine and Valsartan Tablets USP 10mg/160mg in 30 count bottles for CGMP deviations.New Delhi:...
Lupin Somerset facility gets OAI letter from USFDA Farhat Nasim18 March 2019 3:55 AM GMT"The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending...
USFDA Caution: Lupin gets OAI letter for MP plant Medical Dialogues Bureau17 March 2019 4:15 AM GMTLupin has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Mandideep (Unit 1) facility...
OxyContin maker Purdue Pharma exploring bankruptcy: Report Farhat Nasim5 March 2019 3:50 AM GMTSales of OxyContin and other opioids have fallen amid public concern about their addictive nature, and as restrictions on opioid prescribing have been...
Shilpa Medicare gets USFDA nod for Gemcitabine to treat types of cancer Farhat Nasim27 Feb 2019 4:00 AM GMTThe company has received US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA), Gemcitabine for injection...
Alembic Pharma gets USFDA nod for Acetazolamide extended release capsules Farhat Nasim21 Feb 2019 4:15 AM GMTAcetazolamide extended-release capsule is therapeutically equivalent to the reference listed drug, Diamox Sequels, 500 mg, of Teva Branded...
Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution Farhat Nasim17 Feb 2019 4:00 AM GMTThe company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Olopatadine...
Supreme Court refuses interim order on sale of Fortis shares to IHH; final hearing on February 26 Medical Dialogues Bureau16 Feb 2019 7:03 AM GMTA bench comprising Chief Justice Ranjan Gogoi and Justice Sanjiv Khanna said that it would accord final hearing in the case on February 26.New Delhi:...
Mylan launches Advair generic at 70 percent discount in US Farhat Nasim14 Feb 2019 3:45 AM GMTThe treatment, the first generic of Advair, is approved in three doses and will be priced between $93.71 and $153.14, the company said.U.S: Mylan NV...
Novartis Kymriah wins UK backing after initial lymphoma snub Medical Dialogues Bureau3 Feb 2019 4:30 AM GMT"Today's positive announcement regarding access to Kymriah treatment in England and Wales was secured as a result of our close working collaboration...
Dr Reddy's gets four observations from USFDA for Andhra plant Medical Dialogues Bureau19 Jan 2019 4:00 AM GMT"The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today....