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Results For "USFDA-approval"

201 News Found

Strides receives USFDA approval for Gabapentin Tablets
Drug Approval | March 06, 2024

Strides receives USFDA approval for Gabapentin Tablets

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty


Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg
Drug Approval | March 02, 2024

Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg

The product will be launched in March 2024


Orchid Pharma's 'Exblifep' receives USFDA approval
Drug Approval | February 24, 2024

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA


Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP
Drug Approval | February 17, 2024

Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease)


Strides receives USFDA approval for Pregabalin Capsules
Drug Approval | January 26, 2024

Strides receives USFDA approval for Pregabalin Capsules

The Pregabalin capsules has a market size of ~US$248 mn per IQVIA


Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24
Drug Approval | January 03, 2024

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%
Drug Approval | December 27, 2023

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis


Zydus receives USFDA approval USFDA to initiate Phase II clinical trial of ZYIL1 for Parkinson's disease
Drug Approval | December 18, 2023

Zydus receives USFDA approval USFDA to initiate Phase II clinical trial of ZYIL1 for Parkinson's disease

Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation


Lupin receives tentative USFDA approval for Sitagliptin Tablets
Drug Approval | December 18, 2023

Lupin receives tentative USFDA approval for Sitagliptin Tablets

Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus