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Results For "U.S.-Food-and-Drug-Administration"

470 News Found

Granules clears US FDA audit
News | July 21, 2021

Granules clears US FDA audit

The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021


Dr. Reddy's Laboratories asked to pay $462.5 mn to Hatchtech
News | June 17, 2021

Dr. Reddy's Laboratories asked to pay $462.5 mn to Hatchtech

The company is exploring all legal options to challenge the award.


NATCO Pharma receives USFDA approval for Lenalidomide capsules
Policy | May 24, 2021

NATCO Pharma receives USFDA approval for Lenalidomide capsules

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.


Dr. Reddy's launches Ertapenem in US
News | May 12, 2021

Dr. Reddy's launches Ertapenem in US

The INVANZ brand and generic market had U.S. sales of approximately US $205 million MAT for the most recent twelve months ending March 2021 according to IQVIA Health


Dr. Reddy's launches Albendazole tablets in US
News | April 30, 2021

Dr. Reddy's launches Albendazole tablets in US

Dr. Reddy’s Albendazole Tablets, USP are available in 200 mg tablets in bottle count sizes of two


Dr. Reddy's Laboratories launches Sapropterin Dihydrochloride powder for oral solution in US
News | April 08, 2021

Dr. Reddy's Laboratories launches Sapropterin Dihydrochloride powder for oral solution in US

Sapropterin dihydrochloride powder for oral solution is available in 100 mg unit dose


COVID-19 drug Remdesivir now priced at Rs. 899
News | March 25, 2021

COVID-19 drug Remdesivir now priced at Rs. 899

Zydus has made its brand of Remdesivir, Remdac more affordable at Rs. 899 for a 100 mg lyophilized injection.


NATCO receives approval for Everolimus tablets for the US market
News | March 09, 2021

NATCO receives approval for Everolimus tablets for the US market

NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks.


USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis
News | February 24, 2021

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis

The company will review FDA's response and decide on appropriate next steps soon.


Dr. Reddy's Laboratories launches FH Tablets in the U.S. Market
News | February 19, 2021

Dr. Reddy's Laboratories launches FH Tablets in the U.S. Market

Fluphenazine Hydrochloride Tablets, USP are available in 1 mg, 2.5 mg, 5 mg, and 10 mg tablets in 100 bottle count sizes.