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Results For "FDA-approval"

438 News Found

Alvotech and Teva get US FDA approval of Selarsdi
Drug Approval | April 17, 2024

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva


Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg
Drug Approval | April 10, 2024

Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly


Gland Pharma receives USFDA approval for Eribulin Mesylate Injection
Drug Approval | April 07, 2024

Gland Pharma receives USFDA approval for Eribulin Mesylate Injection

The Product is expected to be the first generic approval on the market


Abbott receives FDA approval for TriClip
Drug Approval | April 04, 2024

Abbott receives FDA approval for TriClip

TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery


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