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

Combogesic® IV (acetaminophen and ibuprofen)

Approval Date: Oct 2023

Note: Dosage or Formulation

Indicated for the short term management of mild to moderate acute pain, and the management of moderate to severe pain as an adjunct to opioid analgesics, this drug is now available in an intravenous formulation

Advil Dual Action (acetaminophen and ibuprofen) tablets (OTC)

Approval Date: Feb 2023

Note: First-Time Generic

Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis

Combogesic® (acetaminophen and ibuprofen) tablets

Approval Date: Mar 2023

Note: New Product

Indicated for the short term management of mild to moderate acute pain

Nalfon® (fenoprofen calcium) tablets

Approval Date: Jul 2022

Note: First-Time Generic

An NSAID used for the relief of mild to moderate pain or relief in the signs and symptoms of rheumatoid arthritis or osteoarthritis

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

Belbuca® (buprenorphine) buccal film

Approval Date: Aug 2021

Note: First-Time Generic

This is the first time a generic has been approved for Belbuca. For the management of pain severe enough to require daily, around the clock, long-term opioid treatment for which alternative treatment options are inadequate

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

Medication Name

Approval Date

Category

Description

Combogesic® IV (acetaminophen and ibuprofen)

Oct 2023

Indicated for the short term management of mild to moderate acute pain, and the management of moderate to severe pain as an adjunct to opioid analgesics, this drug is now available in an intravenous formulation

Note: Dosage or Formulation

Advil Dual Action (acetaminophen and ibuprofen) tablets (OTC)

Feb 2023

Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis

Note: First-Time Generic

Combogesic® (acetaminophen and ibuprofen) tablets

Mar 2023

Indicated for the short term management of mild to moderate acute pain

Note: New Product

Nalfon® (fenoprofen calcium) tablets

Jul 2022

An NSAID used for the relief of mild to moderate pain or relief in the signs and symptoms of rheumatoid arthritis or osteoarthritis

Note: First-Time Generic

Seglentis (celecoxib and tramadol hydrochloride) tablets

Oct 2021

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

Note: New Product

Belbuca® (buprenorphine) buccal film

Aug 2021

This is the first time a generic has been approved for Belbuca. For the management of pain severe enough to require daily, around the clock, long-term opioid treatment for which alternative treatment options are inadequate

Note: First-Time Generic

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
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