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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

Kimmtrak (tebentafusp-tebn) Injection

Company: Immunocore
Date of Approval: January 25, 2022

Kimmtrak (tebentafusp-tebn) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Cibinqo (abrocitinib) Tablets

Company: Pfizer Inc.
Date of Approval: January 14, 2022
Treatment for: Atopic Dermatitis

Cibinqo (abrocitinib) is a Janus kinase (JAK) 1 inhibitor for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD).

Ryaltris (mometasone furoate and olopatadine hydrochloride) Nasal Spray

Company: Glenmark Pharmaceuticals Inc.
Date of Approval: January 13, 2022
Treatment for: Allergic Rhinitis

Ryaltris (mometasone and olopatadine) nasal spray is a corticosteroid and antihistamine combination for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older.

Quviviq (daridorexant) Tablets

Company: Idorsia Ltd.
Date of Approval: January 7, 2022
Treatment for: Insomnia

Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) for the treatment of insomnia.

Recorlev (levoketoconazole) Capsules

Company: Xeris Biopharma Holdings
Date of Approval: December 30, 2021
Treatment for: Cushing's Syndrome

Recorlev (levoketoconazole) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome.

Adbry (tralokinumab-ldrm) Injection

Company: LEO Pharma Inc.
Date of Approval: December 27, 2021
Treatment for: Atopic Dermatitis

Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist used for the treatment of moderate-to-severe atopic dermatitis.

Leqvio (inclisiran) Injection

Company: Novartis Pharmaceuticals Corporation
Date of Approval: December 22, 2021
Treatment for: High Cholesterol, Familial Heterozygous

Leqvio (inclisiran) is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA used to reduce low-density lipoprotein cholesterol.

Apretude (cabotegravir) Extended-Release Injectable Suspension

Company: ViiV Healthcare
Date of Approval: December 20, 2021
Treatment for: Pre-Exposure Prophylaxis

Apretude (cabotegravir) is a long-acting injectable integrase strand transfer inhibitor (INSTI) indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Vyvgart (efgartigimod alfa-fcab) Injection

Company: argenx SE
Date of Approval: December 17, 2021
Treatment for: Myasthenia Gravis

Vyvgart (efgartigimod alfa-fcab) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Tezspire (tezepelumab-ekko) Injection

Company: Amgen and AstraZeneca
Date of Approval: December 17, 2021
Treatment for: Asthma

Tezspire (tezepelumab-ekko) is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Yusimry (adalimumab-aqvh) Injection

Company: Coherus BioSciences, Inc.
Date of Approval: December 17, 2021
Treatment for: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis

Yusimry (adalimumab-aqvh) 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, and plaque psoriasis.

Dartisla ODT (glycopyrrolate) Orally Disintegrating Tablets

Company: Edenbridge Pharmaceuticals, LLC
Date of Approval: December 16, 2021
Treatment for: Peptic Ulcer

Dartisla ODT (glycopyrrolate) is an anticholinergic indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

Tarpeyo (budesonide) Delayed Release Capsules - formerly Nefecon

Company: Calliditas Therapeutics AB
Date of Approval: December 15, 2021
Treatment for: IgA Nephropathy

Tarpeyo (budesonide) is a targeted release formulation of the approved corticosteroid budesonide indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN).

Entadfi (finasteride and tadalafil) Capsules

Company: Veru Inc.
Date of Approval: December 9, 2021
Treatment for: Benign Prostatic Hyperplasia

Entadfi (finasteride and tadalafil) is a 5α-reductase inhibitor and phosphodiesterase 5 (PDE5) inhibitor combination indicated for the treatment of urinary tract symptoms caused by benign prostatic hyperplasia (BPH).

Xaciato (clindamycin phosphate) Vaginal Gel - formerly DARE-BV1

Company: Daré Bioscience, Inc.
Date of Approval: December 7, 2021
Treatment for: Bacterial Vaginosis

Xaciato (clindamycin phosphate) is a topical lincosamide antibacterial for the vaginally-administered treatment of bacterial vaginosis in female patients 12 years of age and older.

PreHevbrio (hepatitis B vaccine (recombinant)) Injection

Company: VBI Vaccines Inc.
Date of Approval: November 30, 2021
Treatment for: Hepatitis B Prevention

PreHevbrio (hepatitis B vaccine (recombinant)) is a 3-antigen hepatitis B vaccine indicated for the prevention of hepatitis B virus (HBV) infection in adults.

Cytalux (pafolacianine) Injection

Company: On Target Laboratories, Inc.
Date of Approval: November 29, 2021
Treatment for: Identification of Ovarian Cancer During Surgery

Cytalux (pafolacianine) is a fluorescent imaging agent indicated as an adjunct for the intraoperative identification of malignant lesions in patients with ovarian cancer.

Livtencity (maribavir) Tablets

Company: Takeda Pharmaceutical Company Limited
Date of Approval: November 23, 2021
Treatment for: CMV Infection in Transplant Patients

Livtencity (maribavir) is a cytomegalovirus (CMV) pUL97 kinase inhibitor used for the treatment of post-transplant CMV infection/disease.

Fyarro (sirolimus protein-bound) Lyophilized Powder for Injectable Suspension

Company: Aadi Bioscience, Inc.
Date of Approval: November 22, 2021
Treatment for: Malignant Perivascular Epithelioid Cell Tumor (PEComa)

Fyarro (sirolimus protein-bound particles) is an inhibitor of mechanistic target of rapamycin kinase (mTOR) for the treatment of malignant perivascular epithelioid cell tumor (PEComa).

Lyvispah (baclofen) Oral Granules

Company: Saol Therapeutics, Inc.
Date of Approval: November 22, 2021
Treatment for: Spasticity

Lyvispah (baclofen) is an oral granule formulation of the approved gamma-aminobutyric acid agonist baclofen indicated for the treatment of spasticity.

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