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Results For "Food-and-Drug-Administration"

1066 News Found

Abbott receives FDA clearance for its imaging tech using AI
Digitisation | August 04, 2021

Abbott receives FDA clearance for its imaging tech using AI

Ultreon 1.0 Software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using AI -


Abbott's Freestyle Libre 2 Ios App Cleared In U.S
Drug Approval | August 03, 2021

Abbott's Freestyle Libre 2 Ios App Cleared In U.S

FreeStyle Libre 2 iOS app is the only sensor-based glucose monitoring app that allows users to check their glucose with a compatible iPhone every minute with optional real-time glucose alarms


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


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