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Category: Medmonitor

90 posts found

FDA Approves Hulio for Rheumatoid Arthritis and More

Subcutaneous injections of the new biologic, adalimumab-fkjp, were approved for seven indications.
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FDA Approves Elyxyb Oral Solution for Migraines

Elyxyb (celecoxib) is an NSAID for the acute treatment of migraine with or without aura.
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COVID-19 Updates from the FDA

New developments with diagnostic testing and the use of chloroquine and hydroxychloroquine.
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FDA Approves Two Migraine Drugs and Two NSAIDs

Anjeso and a new Advil formulation target pain, while Nurtec™ and Vyepti™ target migraines.
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FDA Approves Diazepam Nasal Spray and Fast Tracks New Drug for Spinal Cord Injury

A new seizure drug has been approved, and a nerve growth drug advances in clinical trials.
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Three Drug Approvals and a Safety Warning

Migraine, arthritis, and insomnia drug approvals, and a gabapentinoids safety warning.
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New Drug Developments Impacting Comp

A biosimilar to Humira is approved, the FDA Fast Tracks a PTSD drug, and more.
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Recalls Impacting Workers’ Comp

A previous gastrointestinal drug recall expands, while a new recall for an anxiety drug is issued.
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Multiple Companies Recall Ranitidine Hydrochloride Due to Contamination

Indicated for various gastrointestinal concerns, these recalls could impact certain workers’ comp patients.
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FDA Postpones Opioid Approval Decision

NKTR-181 (loxicodegol) was to receive an approval decision by August 29th, but a reevaluation of opioid policy has resulted in a delay.
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FDA Approves First Lyrica Generics

Nine generic versions of Lyrica (pregabalin) have been approved for the treatment of five different medical conditions.
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First-Time Generics Approved for Two Pain Medications

Generic versions of Ultram (tramadol hydrochloride) tablets and Dyloject (diclofenac sodium) injections have been approved by the FDA.
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FDA Reexamines Discontinued Drug for New Pain Applications

Orphengesic Forte has received a decision date of August 14, 2019.
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FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose

The life saving antidote for opioid overdose will soon be available in a consumer-friendly, generic nasal spray.
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FDA Tightens Restrictions for Transmucosal Fentanyl Products

New changes to REMS safety programs will require stronger treatment documentation and oversight.
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