FDA gives fast track status to AstraZeneca’s diabetes drug Farxiga
In July, the US regulators had declined to approve Farxiga as a supplement to insulin in adults with type-1 diabetes where insulin…
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Browsing Tag
USFDA
Strides Pharma acquires USFDA approved manufacturing facility in US
Strides Pharma Science said US business for Strides has seen a significant ramp up over the last few quarters driven by sustained…
USFDA clears Indoco’s Goa Plant II and III
The inspection was held from 27th May, 2019 to 4th June, 2019, where the company had received four observations (483s)
Indoco Remedies gets warning letter from USFDA for oral dosages plant in Goa
The company has received a warning letter from the United States Food and Drug Administration (USFDA) as a result of the…
USFDA inspection at Chennai facility ends with zero observations: Natco Pharma
The inspection was conducted during the period July 8-12, 2019
USFDA issues 12 observations for three Biocon units in Malaysia
The inspection across these three units concluded with 12 observations issued on the Form 483
Alembic Pharma gets USFDA nod for seizure treatment drug
The approval from is for the company’s abbreviated new drug application (ANDA) for Clonazepam orally disintegrating tablets, in…
Lupin receives tentative US FDA approval for Mirabegron ER Tablets
Lupin’s Mirabegron ER Tablets, 25 mg and 50 mg, is a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of…
US group says Novartis MS drug price out of line with benefit
The Boston-based Institute for Clinical and Economic Review (ICER), which has been reviewing Mayzent for months, recommended that…
Aurobindo Pharma gets warning letter from US FDA for Andhra Pradesh unit
The company received a warning letter from the United States Food and Drug Administration (US FDA) related to their unit XI,…