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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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Sovaldi (sofosbuvir) tablets

Approval Date: Jan 2022

Note: First-Time Generic

Indicated for the treatment of Hepatitis C genotypes 1-4 in patients without cirrhosis, or with compensated cirrhosis as part of a combination antiviral treatment regimen.

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Quviviq (daridorexant) tablets

Approval Date: Jan 2022

Note: New Product

Indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

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Apretude (cabotegravir) extended-release injection suspension

Approval Date: Dec 2021

Note: New Product

Indicated to reduce the risk of HIV-1 infection

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Rezvoglar (insulin glargine-aglr) injection

Approval Date: Dec 2021

Note: New Product, Biosimilar

Indicated to improve glycemic control for type 1 and 2 diabetes

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Yusimry (adalimumab-aqvh) injection

Approval Date: Dec 2021

Note: New Product, Biosimilar

The 7th biosimilar approved for adalimumab. For the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, and plaque psoriasis

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Eprontia (topiramate) oral solution

Approval Date: Nov 2021

Note: New Product

Indicated for the treatment of seizures, and for the preventive treatment of migraine

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Amitiza (lubisprostone) capsules

Approval Date: Nov 2021

Note: First-Time Generic

Indicated for the treatment of opioid-induced constipation

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Zimhi (naloxone hydrochloride) injection

Approval Date: Oct 2021

Note: New Product

Indicated for the emergency treatment of known or suspected opioid overdose

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Seglentis (celecoxib and tramadol hydrochloride) tablets

Approval Date: Oct 2021

Note: New Product

A combination opioid agonist and NSAID indicated for the management of acute pain severe enough to require an opioid and for which alternative treatments are inadequate

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Cyltezo (adlimumab-adbm) injection

Approval Date: Oct 2021

Note: Biosimilar

A biosimilar to Humira, this drug is now officially interchangeable with Humira for the treatment  of moderate-to-severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn’s disease, moderate-to-severe ulcerative colitis, and moderate-to-severe chronic plaque psoriasis

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