➡️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.

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

➡️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.

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➡️Recorlev (levoketoconazole) Capsules

Date of Approval: December 30, 2021
Company: Xeris Biopharma Holdings
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

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➡️Ontruzant (trastuzumab-dttb) for Injection

Date of Approval: January 18, 2019
Company: Samsung Bioepis Co., Ltd.
Treatment for: Breast Cancer, Gastric Cancer

Ontruzant (trastuzumab-dttb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

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➡️Tosymra (sumatriptan) Nasal Spray

Date of Approval: January 25, 2019
Company: Dr. Reddy's Laboratories, Inc.
Treatment for: Migraine

Tosymra (sumatriptan) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.

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➡️Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 30, 2019
Company: Mylan N.V.
Treatment for: Asthma, COPD

Wixela Inhub (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Wixela Inhub is the first approved generic version of Advair Diskus.

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➡️Gloperba (colchicine) Oral Solution

Date of Approval: January 30, 2019
Company: Romeg Therapeutics, LLC
Treatment for: Gout

Gloperba (colchicine) is an oral solution formulation of the approved drug colchicine indicated for prophylaxis of gout flares in adults.

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➡️Pizensy (lactitol) Powder for Oral Solution

Date of Approval: February 12, 2020
Company: Braintree Laboratories, Inc.
Treatment for: Chronic Idiopathic Constipation

Pizensy (lactitol) is an osmotic laxative indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

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➡️Nexletol (bempedoic acid) Tablets

Date of Approval: February 21, 2020
Company: Esperion Therapeutics, Inc.
Treatment for: High Cholesterol, Familial Heterozygous

Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-Cholesterol.

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➡️Barhemsys (amisulpride) Injection

Date of Approval: February 26, 2020
Company: Acacia Pharma
Treatment for: Nausea/Vomiting, Postoperative

Barhemsys (amisulpride) is a dopamine-2 (D2) antagonist for the management of post-operative nausea and vomiting (PONV).

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➡️Advil Dual Action (ibuprofen and acetaminophen) Tablets

Date of Approval: February 28, 2020
Company: GSK Consumer Healthcare
Treatment for: Pain

Advil Dual Action (ibuprofen with acetaminophen) is an over-the-counter (OTC) fixed-dose combination of ibuprofen (the nonsteroidal anti-inflammatory drug (NSAID) contained in Advil) and acetaminophen (the active ingredient in Tylenol) for the relief of pain.

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