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Results For "FDA-approval"

460 News Found

Concept Medical receives USFDA approval for sirolimus drug-coated balloon
Drug Approval | April 01, 2024

Concept Medical receives USFDA approval for sirolimus drug-coated balloon

For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure


Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray
Drug Approval | March 20, 2024

Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray

The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024


Zydus receives USFDA approval for Finasteride and Tadalafil capsules
Drug Approval | March 18, 2024

Zydus receives USFDA approval for Finasteride and Tadalafil capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India


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