Medmonitor

An up-to-date timeline of U.S. Food and Drug Administration (FDA) approvals that could potentially impact workers' compensation. These include new drug and indication approvals, new dosages or formulations of existing products, and generics introduced to the market. Click through the interactive timeline below, or select the comprehensive list view.
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Medication Type: Pain

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

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

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

Posimir® (bupivacaine solution) for infiltration use

Approval Date: Feb 2021

Note: new product

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

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

Medication Name

Approval Date

Category

Description

ZYNRELEF (BUPIVACAINE AND MELOXICAM) EXTENDED-RELEASE SOLUTION

May 2021

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

Note: New Product

LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS

Apr 2021

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

Note: First-Time Generic

HYSINGLA® ER (HYDROCODONE BITARTRATE) EXTENDED-RELEASE TABLETS

Mar 2021

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

Note: First-Time Generic

Posimir® (bupivacaine solution) for infiltration use

Feb 2021

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

Note: new product

Acetaminophen injection

Feb 2021

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

Note: New Dosage/Formulation