Medmonitor

Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes

This is the first time a generic has been approved for Xeljanz XR – other formulations of Xeljanz have received generic approvals, but this new generic approval applies to the extended-release formulation. For the treatment of moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis, or ulcerative colitis

This is the first time a generic has been approved for Duexis. For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of developing upper gastrointestinal ulcers

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

This is the first time a generic has been approved for Semglee. For the treatment of Type 1 and Type 2 diabetes, this drug is both a biosimilar to, and interchangeable with Lantus (insulin glargine)

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

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

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

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

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

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

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

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

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

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

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

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

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

For the treatment of severe hypoglycemia in diabetic patients

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

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

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

Indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection

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

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