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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

Mounjaro (tirzepatide) Injection

Company: Eli Lilly and Company
Date of Approval: May 13, 2022
Treatment for: Diabetes, Type 2

Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Radicava ORS (edaravone) Oral Suspension

Company: Mitsubishi Tanabe Pharma Corporation
Date of Approval: May 12, 2022
Treatment for: Amyotrophic Lateral Sclerosis

Radicava ORS is a free radical scavenger indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Voquezna Triple Pak (amoxicillin, clarithromycin, and vonoprazan) Co-Packaged

Company: Phathom Pharmaceuticals, Inc.
Date of Approval: May 3, 2022
Treatment for: Helicobacter Pylori Infection

Voquezna Triple Pak (amoxicillin, clarithromycin, and vonoprazan) is a co-packaged product containing amoxicillin (penicillin class antibacterial), clarithromycin (macrolide antimicrobial), and vonoprazan (potassium-competitive acid blocker (PCAB)) indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults.

Voquezna Dual Pak (amoxicillin and vonoprazan) Co-Packaged

Company: Phathom Pharmaceuticals, Inc.
Date of Approval: May 3, 2022

Voquezna Dual Pak (amoxicillin and vonoprazan) is a co-packaged product containing amoxicillin (penicillin class antibacterial) and vonoprazan ( potassium-competitive acid blocker (PCAB)) indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults.

Camzyos (mavacamten) Capsules

Company: Bristol-Myers Squibb Company
Date of Approval: April 28, 2022
Treatment for: Hypertrophic Cardiomyopathy

Camzyos (mavacamten) is a first-in-class cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

Cuvrior (trientine tetrahydrochloride) Tablets

Company: Orphalan SA
Date of Approval: April 28, 2022
Treatment for: Wilson's Disease

Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine.

Vivjoa (oteseconazole) Capsules

Company: Mycovia Pharmaceuticals, Inc.
Date of Approval: April 26, 2022
Treatment for: Vaginal Yeast Infection

Vivjoa (oteseconazole) is an oral azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

Epsolay (benzoyl peroxide) Cream

Company: Sol-Gel Technologies, Ltd.
Date of Approval: April 22, 2022
Treatment for: Rosacea

Epsolay (benzoyl peroxide) is a topical oxidizing agent for the treatment of inflammatory lesions of rosacea in adults.

Alymsys (bevacizumab-maly) Injection

Company: Amneal Pharmaceuticals LLC
Date of Approval: April 13, 2022
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Alymsys (bevacizumab-maly) is a vascular endothelial growth factor inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer; non-small cell lung cancer; glioblastoma; metastatic renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Vijoice (alpelisib) Tablets

Company: Novartis Pharmaceuticals Corporation
Date of Approval: April 5, 2022
Treatment for: PIK3CA-Related Overgrowth Spectrum

Vijoice (alpelisib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

Igalmi (dexmedetomidine) Sublingual Film

Company: BioXcel Therapeutics, Inc.
Date of Approval: April 5, 2022
Treatment for: Agitation

Igalmi (dexmedetomidine) is a sublingual film formulation of the approved alpha2-adrenergic receptor agonist dexmedetomidine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Tlando (testosterone) Capsules

Company: Antares Pharma, Inc.
Date of Approval: March 28, 2022
Treatment for: Hypogonadism, Male

Tlando (testosterone) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Pluvicto (lutetium lu 177 vipivotide tetraxetan) Injection

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 23, 2022
Treatment for: Prostate Cancer

Pluvicto (lutetium lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent indicated for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

Locametz (gallium Ga 68 gozetotide) Injection

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 23, 2022
Treatment for: Positron Emission Tomography Imaging

Locametz (kit for the preparation of gallium Ga 68 gozetotide injection) after radiolabeling with gallium-68, is a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer.

Xelstrym (dextroamphetamine) Transdermal System

Company: Noven Pharmaceuticals, Inc.
Date of Approval: March 22, 2022
Treatment for: ADHD

Xelstrym (dextroamphetamine) transdermal system is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years and older.

Hyftor (sirolimus) Topical Gel

Company: Nobelpharma America, LLC
Date of Approval: March 22, 2022
Treatment for: Facial Angiofibroma Associated with Tuberous Sclerosis

Hyftor (sirolimus topical gel) is an mTOR inhibitor immunosuppressant indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.

Ztalmy (ganaxolone) Oral Suspension

Company: Marinus Pharmaceuticals, Inc.
Date of Approval: March 18, 2022
Treatment for: CDKL5 Deficiency Disorder

Ztalmy (ganaxolone) is neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).

Opdualag (nivolumab and relatlimab-rmbw) Injection

Company: Bristol-Myers Squibb Company
Date of Approval: March 18, 2022
Treatment for: Melanoma

Opdualag (nivolumab and relatlimab-rmbw) is programmed death receptor-1 (PD-1) blocking antibody and lymphocyte activation gene-3 (LAG-3) blocking antibody combination indicated for the treatment of unresectable or metastatic melanoma.

Nasonex 24HR Allergy (mometasone furoate monohydrate) Nasal Spray

Company: Perrigo Company
Date of Approval: March 17, 2022
Treatment for: Allergic Rhinitis

Nasonex 24HR Allergy (mometasone furoate monohydrate) is a corticosteroid nasal spray available over-the-counter for the temporary relief of the symptoms of hayfever or other upper respiratory allergies.

Adlarity (donepezil) Transdermal System

Company: Corium, Inc.
Date of Approval: March 11, 2022
Treatment for: Alzheimer's Disease

Adlarity (donepezil transdermal system) is a once-weekly transdermal formulation of the approved acetylcholinesterase inhibitor donepezil indicated for the treatment of Alzheimer’s type dementia.

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