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Category: Medmonitor

83 posts found

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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Tanezumab Trials Yield Positive Results for Pain Management

Phase 3 clinical trials for this non-opioid drug demonstrate significant reductions in pain for osteoarthritis and chronic low-back pain.
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FDA Nudges Developers to Create Over-the-Counter Naloxone

The FDA created special drug labels to clear a development hurdle and encourage manufacturers.
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FDA Approves Two New Strengths of Apadaz

The opioid prodrug for acute pain will soon be available in both a stronger and weaker dose.
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FDA Approves First Prescription App for Opioid Use Disorder

The reSET-O app uses cognitive behavioral therapy techniques to assist patients engaged in medication-assisted therapy for opioid dependence.
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FDA Approves New Opioid, Dsuvia

Five-to-ten times stronger than fentanyl, this drug is not for consumer use, and many claim it could worsen the opioid crisis.
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DEA Reschedules Epidiolex

The marijuana-derived seizure drug now sits at schedule V, facing far fewer prescribing and dispensing restrictions.
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FDA Approves New Dosage for Opioid Dependence Therapy

Cassipa (buprenorphine and naloxone) sublingual film delivers a new dosage for the treatment of opioid dependence.
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