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Results For "United-States-Food-and-Drug-Administration"

281 News Found

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


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


Caplin Steriles gets USFDA approval
News | April 23, 2021

Caplin Steriles gets USFDA approval

The injection comes in multiple formats


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).


Unichem Laboratories receives ANDA approval for Apremilast Tablets
News | February 20, 2021

Unichem Laboratories receives ANDA approval for Apremilast Tablets

Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .


Lupin receives approval for Droxidopa capsules
News | February 20, 2021

Lupin receives approval for Droxidopa capsules

Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, are indicated for the treatment of orthostatic dizziness


Lupin launches posaconazole delayed-release tablets
News | February 18, 2021

Lupin launches posaconazole delayed-release tablets

posaconazole delayed-release tablets 100 mg are the generic equivalent of Noxafil.