Zavzpret (zavegepant) nasal spray is a calcitonin gene-related peptide (CGRP) receptor antagonist.
The product is used as an anti-inflammatory intended to relieve ocular irritation and/or swelling.
The FDA panel reviewed data from 5 clinical studies, including the phase 3 AReSVi 006 trial.
The sNDA is supported by data from the phase 3 DINAMO trial, which include patients 10 to less than 18 years of age with type 2 diabetes who are currently receiving metformin, insulin, or both.
Elyxyb is a ready-to-use oral solution formulation of celecoxib, a nonsteroidal anti-inflammatory drug.
The BLA is supported by data from the pivotal PULSAR and PHOTON trials.
The studies evaluated routine clinical practice data from more than 800 hospitals in the US.
The designation is supported by data from the ongoing phase 2 KEYNOTE-942 study, which included 157 patients with stage III/IV melanoma following complete resection.
The approval was based on data from the phase 3 DERBY and OAKS studies.
The letters cite violations related to drug misbranding failing to bear adequate directions for their intended use(s).
Nirsevimab is a long-acting anti-RSV for nirsevimab for the prevention of RSV lower.
The approval was based on data from a clinical program that included 23 clinical trials enrolling more than 5000 adults with type 2 diabetes mellitus.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
CyclASol is an investigational topical treatment of cyclosporine that contains no oils or surfactants and is preservative-free.
Iheezo is a sterile, preservative-free, single-patient use, ophthalmic gel preparation.
The sBLA is supported by data from a phase 3 trial that evaluated lanadelumab to prevent acute HAE attacks in 21 patients 2 to less than 12 years of age.
Tarcocimab tedromer is an investigational VEGF inhibitor designed to improve bioavailability and intraocular half-life using the Company’s antibody biopolymer conjugate platform.
Pegcetacoplan is a targeted C3 therapy that works by regulating excessive activation of the complement cascade.
The approval was based on data from the phase 2 IMCgp100-202 trial that assessed Kimmtrak in 378 HLA-A*02:01-positive adults with previously untreated metastatic uveal melanoma.
Pataday Once Daily Relief Extra Strength is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Refresh Digital is designed to protect tears from evaporating due to incomplete blinking during digital device use.
The NDA submission is supported by data from the phase 3 MIST-1 and MIST-2 studies.
Previously, the device had only been approved in those with episodic migraine.
The application is supported by data from the double-blind, placebo-controlled phase 3 VOYAGER PAD trial.
EyeArt is the first FDA-cleared AI technology for autonomous detection of more than mild diabetic retinopathy and vision-threatening diabetic retinopathy.
The FDA has granted Fast Track designation to Zimura (avacincaptad pegol; Iveric Bio) for the treatment of geographic atrophy secondary to dry age-related macular degeneration.
Cases of severe vision loss, inflammation, and potential retinal vasculitis following treatment with Beovu (brolucizumab) injection are currently being investigated by the product’s manufacturer Novartis.
Cystinosis is a rare, multisystem genetic disorder caused by an accumulation of cystine crystals throughout the body, including the eyes.
The Food and Drug Administration (FDA) has approved Tepezza™ (teprotumumab-trbw; Horizon Therapeutics) for the treatment of thyroid eye disease.
