Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 37

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

378 News Found

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


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.