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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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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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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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