➡️(fexinidazole) Tablets

Date of Approval: July 16, 2021
Company: Drugs for Neglected Diseases Initiative
Treatment for: Trypanosomiasis

Fexinidazole is a nitroimidazole antibacterial indicated for the treatment of human African trypanosomiasis (African sleeping sickness) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.

https://news.1rj.ru/str/ppdprogram

➡️Bylvay (odevixibat) Capsules

Date of Approval: July 20, 2021
Company: Albireo Pharma, Inc.
Treatment for: Progressive Familial Intrahepatic Cholestasis (PFIC)

Bylvay (odevixibat) is an ileal bile acid transport (IBAT) inhibitor for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

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➡️Twyneo (tretinoin and benzoyl peroxide) Cream

Date of Approval: July 26, 2021
Company: Sol-Gel Technologies, Ltd.
Treatment for: Acne

Twyneo (tretinoin and benzoyl peroxide) is a topical retinoid and antibacterial fixed-dose combination for the treatment of acne vulgaris in adults and children 9 years of age and older.

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➡️Korsuva (difelikefalin) Injection

Date of Approval: August 23, 2021
Company: Cara Therapeutics, Inc.
Treatment for: Chronic Kidney Disease-Associated Pruritus

Korsuva (difelikefalin) is a selective peripheral kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

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➡️Skytrofa (lonapegsomatropin-tcgd) for Injection

Date of Approval: August 25, 2021
Company: Ascendis Pharma A/S
Treatment for: Pediatric Growth Hormone Deficiency

Skytrofa (lonapegsomatropin-tcgd) is a human growth hormone used once-weekly for the treatment of pediatric growth hormone deficiency.

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➡️Trudhesa (dihydroergotamine mesylate) Nasal Spray

Date of Approval: September 2, 2021
Company: Impel NeuroPharma, Inc.
Treatment for: Migraine

Trudhesa (dihydroergotamine mesylate) is a nasally administered dihydroergotamine (DHE) formulation for the acute treatment of migraine with or without aura in adults.

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➡️Tivdak (tisotumab vedotin-tftv) Lyophilized Powder for Injection

Date of Approval: September 20, 2021
Company: Seagen Inc.
Treatment for: Cervical Cancer

Tivdak (tisotumab vedotin-tftv) is a tissue factor-directed antibody and microtubule inhibitor conjugate for the treatment of patients with recurrent or metastatic cervical cancer.

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➡️Opzelura (ruxolitinib) Cream

Date of Approval: September 21, 2021
Company: Incyte
Treatment for: Atopic Dermatitis

Opzelura (ruxolitinib) cream is a topical Janus kinase (JAK) inhibitor used for the treatment of atopic dermatitis.

https://news.1rj.ru/str/ppdprogram

➡️Qulipta (atogepant) Tablets

Date of Approval: September 28, 2021
Company: AbbVie Inc.
Treatment for: Migraine Prevention

Qulipta (atogepant) is an oral, calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of episodic migraine in adults.

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➡️Tavneos (avacopan) Capsules

Date of Approval: October 7, 2021
Company: ChemoCentryx, Inc.
Treatment for: ANCA-Associated Vasculitis

Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist for the adjunctive treatment of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.

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➡️Zimhi (naloxone hydrochloride) Injection

Date of Approval: October 15, 2021
Company: Adamis Pharmaceuticals Corporation
Treatment for: Opioid Overdose

Zimhi (naloxone hydrochloride) is a high-dose formulation of the approved opioid antagonist naloxone for use in the treatment of opioid overdose.

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➡️Tyrvaya (varenicline) Nasal Spray

Date of Approval: October 15, 2021
Company: Oyster Point Pharma, Inc.
Treatment for: Dry Eye Disease

Tyrvaya (varenicline) is a nasally administered selective cholinergic agonist for the treatment of the signs and symptoms of dry eye disease.

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➡️Scemblix (asciminib) Tablets

Date of Approval: October 29, 2021
Company: Novartis
Treatment for: Chronic Myelogenous Leukemia

Scemblix (asciminib) is a tyrosine kinase inhibitor used for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

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➡️Eprontia (topiramate) Oral Solution

Date of Approval: November 5, 2021
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Epilepsy, Migraine Prevention

Eprontia (topiramate) is a ready-to-use liquid formulation of the approved anticonvulsant topiramate for use in the treatment of epilepsy and the preventive treatment of migraine.

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

Date of Approval: December 7, 2021
Company: Daré Bioscience, Inc.
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.

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➡️Tarpeyo (budesonide) Delayed Release Capsules - formerly Nefecon

Date of Approval: December 15, 2021
Company: Calliditas Therapeutics AB
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).

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➡️Dartisla ODT (glycopyrrolate) Orally Disintegrating Tablets

Date of Approval: December 16, 2021
Company: Edenbridge Pharmaceuticals, LLC
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.

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➡️Tezspire (tezepelumab-ekko) Injection

Date of Approval: December 17, 2021
Company: Amgen and AstraZeneca
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.

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➡️Vyvgart (efgartigimod alfa-fcab) Injection

Date of Approval: December 17, 2021
Company: argenx SE
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.

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➡️Yusimry (adalimumab-aqvh) Injection

Date of Approval: December 17, 2021
Company: Coherus BioSciences, Inc.
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.

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➡️Leqvio (inclisiran) Injection

Date of Approval: December 22, 2021
Company: Novartis
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.

https://news.1rj.ru/str/ppdprogram