Aptiom® (eslicarbazepine acetate) tablets
Approval Date: Jun 2021
This is the first time a generic has been approved for Aptiom. For the adjunctive treatment of partial-onset seizures
ZYNRELEF™ (BUPIVACAINE AND MELOXICAM) EXTENDED-RELEASE SOLUTION
Approval Date: 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
LYBALVI™ (OLANZAPINE AND SAMIDORPHAN) TABLETS FOR ORAL USE
Approval Date: May 2021
A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder
KLOXXADO™ (NALOXONE HYDROCHLORIDE) NASAL SPRAY
Approval Date: Apr 2021
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
LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS
Approval Date: 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
HYSINGLA® ER (HYDROCODONE BITARTRATE) EXTENDED-RELEASE TABLETS
Approval Date: 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
ZEGALOGUE® (DASIGLUCAGON) INJECTION FOR SUBCUTANEOUS USE
Approval Date: Mar 2021
For the treatment of severe hypoglycemia in diabetic patients
Posimir® (bupivacaine solution) for infiltration use
Approval Date: Feb 2021
Indicated for 72-hour post-surgical analgesia following shoulder surgery
Acetaminophen injection
Approval Date: 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
Cabenuva (cabotegravir and rilpivirine extended-release injectable suspension)
Approval Date: Jan 2021
A complete regimen for the treatment of HIV-1 infection to replace current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure. This is the first FDA-approved injectable, complete regimen for HIV, administered once a month
Norvir® (ritonavir) capsules
Approval Date: Dec 2020
Indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection
Veklury® (remdesivir) injection for intravenous use
Approval Date: Oct 2020
Indicated for the treatment of COVID-19 cases requiring hospitalization. Veklury should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care
Xeljanz® (tofacitinib) oral solution
Approval Date: Sep 2020
A new oral solution formulation, this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis
Medication Name
Approval Date
Category
Description
Aptiom® (eslicarbazepine acetate) tablets
This is the first time a generic has been approved for Aptiom. For the adjunctive treatment of partial-onset seizures
ZYNRELEF™ (BUPIVACAINE AND MELOXICAM) EXTENDED-RELEASE SOLUTION
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
LYBALVI™ (OLANZAPINE AND SAMIDORPHAN) TABLETS FOR ORAL USE
A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder
KLOXXADO™ (NALOXONE HYDROCHLORIDE) NASAL SPRAY
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
LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS
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
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
ZEGALOGUE® (DASIGLUCAGON) INJECTION FOR SUBCUTANEOUS USE
For the treatment of severe hypoglycemia in diabetic patients
Posimir® (bupivacaine solution) for infiltration use
Indicated for 72-hour post-surgical analgesia following shoulder surgery
Acetaminophen injection
A new 500 mg dose indicated for the management of mild to moderate pain, or moderate to severe pain with adjudicative opioid analgesics
Cabenuva (cabotegravir and rilpivirine extended-release injectable suspension)
A complete regimen for the treatment of HIV-1 infection to replace current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure. This is the first FDA-approved injectable, complete regimen for HIV, administered once a month
Norvir® (ritonavir) capsules
Indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection
Veklury® (remdesivir) injection for intravenous use
Indicated for the treatment of COVID-19 cases requiring hospitalization. Veklury should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care
Xeljanz® (tofacitinib) oral solution
A new oral solution formulation, this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis
