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Results For "Food-and-Drug-Administration"

1013 News Found

Caplin gets USFDA approval for Sumatriptan
News | July 15, 2021

Caplin gets USFDA approval for Sumatriptan

Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache


Unichem receives tentative approval for ANDA of Sitagliptin tablets
News | July 11, 2021

Unichem receives tentative approval for ANDA of Sitagliptin tablets

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets
News | July 01, 2021

Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets

TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg


Lupin Launches Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in the US
News | June 27, 2021

Lupin Launches Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in the US

It is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.


Cipla receives final approval for generic version of Brovana
News | June 24, 2021

Cipla receives final approval for generic version of Brovana

Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana


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.


Lupin receives U.S. FDA approval for HIV-1 drug
Pharma | June 08, 2021

Lupin receives U.S. FDA approval for HIV-1 drug

Emtricitabine and Tenofovir Disoproxil Fumarate tablets had estimated annual sales of US $2.1 billion in the U.S. according to IQVIA MAT March 2021


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