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US Food and Drug Administration (USFDA) News
US Food and Drug Administration (USFDA)
Alembic Pharma's JV Aleor gets USFDA nod for generic skin conditions ointment
Tue, Mar 05, 2019
According to IQVIA , Clobetasol Propionate ointment USP, 0.05 per cent, has an estimated market size of USD 63 million for twelve months ending December 2018, Alembic Pharmaceuticals said.
Sun Pharma receives USFDA nod ophthalmic solution used to treat dry eye disease
Thu, Aug 16, 2018
Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated, Abhay Gandhi, CEO, North America, Sun Pharma.
Orchid Pharma gets inspection report from US regulator
Mon, Jan 08, 2018
The company's stock closed 4.93% up on the BSE today
Glenmark launches generic version of cholesterol drug Zetia in US market
Mon, Dec 12, 2016
Glenmark and its partner Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe.
Marksans Pharma shares jump 11% on USFDA nod for allergic drug
Mon, Sep 26, 2016
The company said that USFDA has granted not for an Abbreviated New Drug Application (ANDA) for Loratadine liquid filled capsules 10 mg.
Lupin shares fall 2% despite receiving approval for Acotiamide tablets
Mon, Aug 22, 2016
Naresh Gupta, President, Lupin Limited said “We have a rich legacy of having introduced novel treatments to address unmet medical needs in the country. I am sure that the approval of Acotiamide would go a long way in addressing an otherwise common but unmet medical need for a safe and effective drug for the management of dyspepsia.”
Aurobindo Pharma gets USFDA approval for blood pressure drug; shares up over 1%
Tue, Apr 26, 2016
The company received approval from USFDA for a generic version of blood pressure treatment drugs
Aurobindo Pharma receives USFDA approval for gastro reflux drug
Fri, Apr 22, 2016
The company said the launch of the product is based on the settlement terms/litigation outcome with AstraZeneca.