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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic approvals, Approval process, New indications & dosage forms

Abrysvo (respiratory syncytial virus vaccine) Injection

Company: Pfizer Inc.
Date of Approval: May 31, 2023
Treatment for: Respiratory Syncytial Virus

Abrysvo (respiratory syncytial virus vaccine) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.

Inpefa (sotagliflozin) Tablets

Company: Lexicon Pharmaceuticals, Inc.
Date of Approval: May 26, 2023
Treatment for: Heart Failure

Inpefa (sotagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the treatment of heart failure.

Paxlovid (nirmatrelvir and ritonavir) Tablets (co-packaged)

Company: Pfizer Inc.
Date of Approval: May 25, 2023
Treatment for: COVID-19

Paxlovid (nirmatrelvir and ritonavir) is a co-packaged product containing nirmatrelvir, a SARS-CoV-2 main protease inhibitor, and ritonavir, a HIV-1 protease inhibitor and CYP3A inhibitor, indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

Posluma (flotufolastat F 18) Injection

Company: Blue Earth Diagnostics
Date of Approval: May 25, 2023
Treatment for: Positron Emission Tomography Imaging, Diagnosis and Investigation

Posluma (flotufolastat F 18) a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Brixadi (buprenorphine) Extended-Release Injection

Company: Braeburn Inc.
Date of Approval: May 23, 2023
Treatment for: Opioid Use Disorder

Brixadi (buprenorphine) is a partial opioid agonist for use in the treatment of opioid use disorder.

Xacduro (sulbactam and durlobactam (co-packaged)) Kit for Injection

Company: Innoviva, Inc.
Date of Approval: May 23, 2023
Treatment for: Acinetobacter Pneumonia

Xacduro (sulbactam and durlobactam) is a co-packaged product containing the beta-lactam antibacterial sulbactam, and the beta lactamase inhibitor durlobactam for use in the treatment of serious infections caused by Acinetobacter.

Yuflyma (adalimumab-aaty) Injection

Company: Celltrion, Inc.
Date of Approval: May 23, 2023
Treatment for: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Yuflyma (adalimumab-aaty) is a tumor necrosis factor (TNF) blocker biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Opvee (nalmefene hydrochloride) Nasal Spray

Company: Opiant Pharmaceuticals, Inc.
Date of Approval: May 22, 2023
Treatment for: Opioid Overdose

Opvee (nalmefene hydrochloride) is a nasal spray formulation of the approved opioid antagonist nalmefene hydrochloride for use in the treatment of opioid overdose.

Epkinly (epcoritamab-bysp) Injection

Company: AbbVie Inc.
Date of Approval: May 19, 2023
Treatment for: Diffuse Large B-Cell Lymphoma

Epkinly (epcoritamab-bysp) is a bispecific CD20-directed CD3 T-cell engager for use in the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Vyjuvek (beremagene geperpavec-svdt) Topical Gel

Company: Krystal Biotech, Inc.
Date of Approval: May 19, 2023
Treatment for: Dystrophic Epidermolysis Bullosa

Vyjuvek (beremagene-geperpavec-svdt) is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy for the treatment of wounds in patients dystrophic epidermolysis bullosa.

Miebo (perfluorohexyloctane) Ophthalmic Solution - formerly NOV03

Company: Bausch & Lomb Inc.
Date of Approval: May 18, 2023
Treatment for: Dry Eye Disease

Miebo (perfluorohexyloctane) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease.

Skinvive by Juvederm (hyaluronic acid and lidocaine) Injectable Gel

Company: AbbVie Inc.
Date of Approval: May 15, 2023
Treatment for: Facial Wrinkles

Skinvive by Juvéderm (hyaluronic acid and lidocaine) is an intradermal microdroplet injection containing a dermal filler and a local anesthetic used to improve skin smoothness of the cheeks in adults over the age of 21.

Veozah (fezolinetant) Tablets

Company: Astellas Pharma US, Inc.
Date of Approval: May 12, 2023
Treatment for: Menopausal Disorders, Hot Flashes

Veozah (fezolinetant) is a selective neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Elfabrio (pegunigalsidase alfa-iwxj) Injection

Company: Protalix BioTherapeutics, Inc.
Date of Approval: May 9, 2023
Treatment for: Fabry Disease

Elfabrio (pegunigalsidase alfa-iwxj) is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease.

Mydcombi (phenylephrine hydrochloride and tropicamide) Ophthalmic Spray

Company: Eyenovia, Inc.
Date of Approval: May 5, 2023
Treatment for: Pupillary Dilation

Mydcombi (phenylephrine hydrochloride and tropicamide) is an alpha-1 adrenergic receptor agonist and anticholinergic fixed-combination ophthalmic spray indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.

Arexvy (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection

Company: GlaxoSmithKline
Date of Approval: May 3, 2023
Treatment for: Prevention of RSV Infection

Arexvy (respiratory syncytial virus vaccine, adjuvanted) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.

Lumryz (sodium oxybate) Granules for Extended-Release Oral Suspension

Company: Avadel Pharmaceuticals plc
Date of Approval: May 1, 2023
Treatment for: Narcolepsy

Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate indicated for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Uzedy (risperidone) Extended-Release Injectable Suspension

Company: Teva Pharmaceuticals and MedinCell
Date of Approval: April 28, 2023
Treatment for: Schizophrenia

Uzedy (risperidone) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia in adults.

Abilify Asimtufii (aripiprazole) Extended-Release Injectable Suspension

Company: Otsuka Pharmaceutical Co., Ltd
Date of Approval: April 27, 2023
Treatment for: Schizophrenia, Bipolar Disorder

Abilify Asimtufii (aripiprazole) is a long-acting injectable atypical antipsychotic for the treatment of schizophrenia and bipolar I disorder.

Vowst (fecal microbiota spores, live-brpk) Capsules - formerly SER-109

Company: Seres Therapeutics, Inc.
Date of Approval: April 26, 2023
Treatment for: Prevention of Recurrent Clostridioides difficile Infection

Vowst (fecal microbiota spores, live-brpk) is an oral microbiome therapeutic indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.

FDA drug approvals archive

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