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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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WEGOVY (SEMAGLUTIDE) INJECTION

Approval Date: Jun 2021

Note: New Product

For chronic weight management with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) for use in addition to a reduced calorie diet and increased physical activity

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ADUHELM (ADUCANUMAB-AVWA) INJECTION

Approval Date: Jun 2021

Note: New Product

A first-of-its-kind, biologic treatment for Alzheimer’s disease. This drug is the first new Alzheimer’s drug since 2003

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Xeljanz® (tofacitnib) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Xeljanz. For the treatment of moderate-to-severe active rheumatoid arthritis, and psoriatic arthritis

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Kaletra® (lopinavir and ritonavir) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Kaletra. For the treatment of HIV-1 infection

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Intelence® (etravirine) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Intelence. For the treatment of HIV-1 infection in treatment-experienced patients

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Perforomist® (formoterol fumarate) inhalation solution

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Perforomist. For the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

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Brovana® (arformoterol tartrate) inhalation solution

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Brovana. For the long-term, twice daily administration in the maintenance of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

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Aptiom® (eslicarbazepine acetate) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Aptiom. For the adjunctive treatment of partial-onset seizures

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ZYNRELEF (BUPIVACAINE AND MELOXICAM) EXTENDED-RELEASE SOLUTION

Approval Date: May 2021

Note: New Product

A combination of an amide local anesthetic and an NSAID for postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty

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LYBALVI (OLANZAPINE AND SAMIDORPHAN) TABLETS FOR ORAL USE

Approval Date: May 2021

Note: New Product

A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder

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