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

432 News Found

Lupin receives tentative approval for Brexpiprazole tablets
Drug Approval | October 06, 2021

Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India


Lupin launches Droxidopa capsules in the US
Drug Approval | September 29, 2021

Lupin launches Droxidopa capsules in the US

Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA


Zydus Cadila’s Sitagliptin base tablets receive tentative approval from US FDA
Drug Approval | September 06, 2021

Zydus Cadila’s Sitagliptin base tablets receive tentative approval from US FDA

Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)


FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
Drug Approval | August 19, 2021

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump

It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min


Ind-Ra predicts growth in US sales for Indian pharma from H2FY22
News | August 18, 2021

Ind-Ra predicts growth in US sales for Indian pharma from H2FY22

Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume


Lupin receives tentative U.S. FDA approval for Brivaracetam tablets
Drug Approval | August 17, 2021

Lupin receives tentative U.S. FDA approval for Brivaracetam tablets

Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older


Unichem Labs receive ANDA approval for Metformin Hydrochloride
News | August 13, 2021

Unichem Labs receive ANDA approval for Metformin Hydrochloride

It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
Drug Approval | August 12, 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

It’s an AB-rated generic therapeutic version of Durezol


Alkem launches Ibuprofen and Famotidine tablets in US
News | August 07, 2021

Alkem launches Ibuprofen and Famotidine tablets in US

Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg


Alkem launch two drugs in US
News | August 04, 2021

Alkem launch two drugs in US

Ibuprofen and Famotidine tablets approved by FDA