Tag: FDA Approved

FDA Approves First Treatment for Thyroid Eye Disease

January 21, the U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues ...

FDA Has Approved a New Indication for Ozempic® (semaglutide)

Novo Nordisk Jan. 16 announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic® (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse ca...

VALTOCO Granted Orphan Drug Exclusivity by the FDA

Neurelis, Inc., 13 January, announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequ...

FDA Approves Avapritinib, the First Targeted Gastrointestinal Stromal Tumour Treatment

January 09, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spre...

Indoco Remedies Received Final Approval of ANDA for Febuxostat

Indoco Remedies received final approval of its ANDA for Febuxostat Tablets 40 mg and 80 mg, which is therapeutically equivalent to the Reference Listed Drug (RLD), viz., Uloric Tablets 40 mg and 80 mg...

FDA Approved Generic Version of Febuxostat

Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approval for their generic version of Febuxostat 40mg and 80mg tab...

FDA Approved Two Applications for First Generics of Eliquis

The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular...

FDA Approved Ubrelvy for Acute Treatment of Migraine

migraine
The U.S. Food and Drug Administration approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults....

Caplyta Gained FDA Clearance for Schizophrenia Treatment

fda
Intra-Cellular Therapies said that the FDA approved Caplyta (lumateperone) for the treatment of schizophrenia in adults, with launch of the oral, once-daily medicine targeted for late in the first qua...

FDA Approved Daiichi Sankyo Enhertu

The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or met...

FDA Approved Merck Ervebo

The U.S. Food and Drug Administration announced the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 yea...

FDA Approved Astellas Padcev

The U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically ...

FDA Approved Pfizer and Astellas Pharma XTANDI®

Pfizer Inc. and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for XTANDI® (enzalutamide) for the treatment of patient...

FDA Cleared for Marketing in the U.S. First Fully Disposable Duodenoscope

The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and acce...

FDA Approved Use of Vascepa

cardiology
The U.S. Food and Drug Administration approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyce...

FDA Approved First Test to Aid in Newborn Screening for DMD

The U.S. Food and Drug Administration authorized marketing of the first test to aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle d...