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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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KLOXXADO (NALOXONE HYDROCHLORIDE) NASAL SPRAY

Approval Date: Apr 2021

Note: New Product

For the emergency treatment of known or suspected opioid overdose. While other naloxone sprays were previously available in 2 mg and 4 mg doses, this drug has been approved at an 8 mg dose

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LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS

Approval Date: Apr 2021

Note: First-Time Generic

For the management of neuropathic pain associated with diabetic neuropathy; post-herpetic neuralgia. While previous generic versions of Lyrica have been approved in the past, this generic approval is for the Extended-Release tablets

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HYSINGLA® ER (HYDROCODONE BITARTRATE) EXTENDED-RELEASE TABLETS

Approval Date: Mar 2021

Note: First-Time Generic

For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

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ZEGALOGUE® (DASIGLUCAGON) INJECTION FOR SUBCUTANEOUS USE

Approval Date: Mar 2021

Note: New Product

For the treatment of severe hypoglycemia in diabetic patients

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Posimir® (bupivacaine solution) for infiltration use

Approval Date: Feb 2021

Note: new product

Indicated for 72-hour post-surgical analgesia following shoulder surgery

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Acetaminophen injection

Approval Date: Feb 2021

Note: New Dosage/Formulation

A new 500 mg dose indicated for the management of mild to moderate pain, or moderate to severe pain with adjudicative opioid analgesics

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Cabenuva (cabotegravir and rilpivirine extended-release injectable suspension)

Approval Date: Jan 2021

Note: New Product

A complete regimen for the treatment of HIV-1 infection to replace current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure. This is the first FDA-approved injectable, complete regimen for HIV, administered once a month

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Norvir® (ritonavir) capsules

Approval Date: Dec 2020

Note: First-Time Generic

Indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection

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Veklury® (remdesivir) injection for intravenous use

Approval Date: Oct 2020

Note: new product

Indicated for the treatment of COVID-19 cases requiring hospitalization. Veklury should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care

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Xeljanz® (tofacitinib) oral solution

Approval Date: Sep 2020

Note: new dosage or formulation

A new oral solution formulation, this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis

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