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Results For "Food-and-Drug-Administration"

1066 News Found

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


Caplin Steriles gets USFDA approval
News | April 23, 2021

Caplin Steriles gets USFDA approval

The injection comes in multiple formats


NATCO receives approval for Ibrutinib tablets from ANDA
News | April 11, 2021

NATCO receives approval for Ibrutinib tablets from ANDA

The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths


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.


Lupin launches penicillamine tablets USP
News | March 04, 2021

Lupin launches penicillamine tablets USP

Penicillamine Tablets USP, 250 mg (RLD: Depen) had estimated annual sales of USD 5 million in the U.S. (IQVIA MAT December 2020).


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.