➡️Nayzilam (midazolam) Nasal Spray

Date of Approval: May 17, 2019
Company: UCB
Treatment for: Seizure Clusters

Nayzilam (midazolam) is a nasally administered benzodiazepine indicated for the acute treatment of seizure clusters.


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➡️Myxredlin (insulin human in sodium chloride) Injection

Date of Approval: June 20, 2019
Company: Baxter International Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Myxredlin (insulin human in sodium chloride) is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

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➡️Katerzia (amlodipine benzoate) Oral Suspension

Date of Approval: July 8, 2019
Company: Silvergate Pharmaceuticals, Inc.
Treatment for: High Blood Pressure, Coronary Artery Disease

Katerzia (amlodipine benzoate) is a calcium channel blocker in an oral suspension formulation indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, and coronary artery disease in adults.


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➡️AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: July 15, 2019
Treatment for: Asthma

AirDuo Digihaler (fluticasone propionate and salmeterol) is a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) combination therapy for the treatment of asthma in patients aged 12 years and older.


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➡️Recarbrio (imipenem, cilastatin, and relebactam) for Injection

Date of Approval: July 16, 2019
Company: Merck
Treatment for: Urinary Tract Infection, Intraabdominal Infection, Nosocomial Pneumonia

Recarbrio (imipenem, cilastatin, and relebactam) is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.

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➡️Baqsimi (glucagon) Nasal Powder

Date of Approval: July 24, 2019
Company: Eli Lilly and Company
Treatment for: Hypoglycemia

Baqsimi (glucagon) is a nasally administered antihypoglycemic agent indicated for the treatment of severe hypoglycemia in diabetes patients ages 4 years and older.


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➡️Accrufer (ferric maltol) Capsules - formerly Feraccru

Date of Approval: July 25, 2019
Company: Shield Therapeutics plc
Treatment for: Iron Deficiency

Accrufer (ferric maltol) is a non-salt formulation of ferric iron for the treatment of iron deficiency in adults.


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➡️(pretomanid) Tablets

Date of Approval: August 14, 2019
Company: TB Alliance
Treatment for: Tuberculosis, Resistant

Pretomanid is a nitroimidazooxazine antimycobacterial indicated for use in combination with bedaquiline and linezolid (the BPaL regimen) for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).


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➡️Wakix (pitolisant) Tablets

Date of Approval: August 14, 2019
Company: Harmony Biosciences, LLC
Treatment for: Narcolepsy

Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.


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➡️Rinvoq (upadacitinib) Extended-Release Tablets

Date of Approval: August 16, 2019
Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ulcerative Colitis, Ankylosing Spondylitis

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis.

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➡️Xenleta (lefamulin) Tablets and Injection

Date of Approval: August 19, 2019
Company: Nabriva Therapeutics plc
Treatment for: Pneumonia

Xenleta (lefamulin) is a first-in-class, semi-synthetic pleuromutilin antibiotic for the treatment of community-acquired bacterial pneumonia (CABP).

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➡️Ibsrela (tenapanor) Tablets

Date of Approval: September 12, 2019
Company: Ardelyx, Inc
Treatment for: Irritable Bowel Syndrome

Ibsrela (tenapanor) is a first-in-class, sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

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➡️Rybelsus (semaglutide) Tablets

Date of Approval: September 20, 2019
Company: Novo Nordisk
Treatment for: Diabetes, Type 2

Rybelsus (semaglutide) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of adults with type 2 diabetes mellitus.


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➡️Aklief (trifarotene) Topical Cream

Date of Approval: October 4, 2019
Company: Galderma
Treatment for: Acne

Aklief (trifarotene) is a topical retinoid indicated for the treatment of acne vulgaris in patients 9 years of age and older.


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➡️Quzyttir (cetirizine hydrochloride) Injection

Date of Approval: October 4, 2019
Company: TerSera Therapeutics LLC
Treatment for: Urticaria

Quzyttir (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

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➡️Reyvow (lasmiditan) Tablets

Date of Approval: October 11, 2019
Company: Eli Lilly and Company
Treatment for: Migraine

Reyvow (lasmiditan) is a serotonin (5-HT)1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.


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➡️Secuado (asenapine) Transdermal System

Date of Approval: October 11, 2019
Company: Noven Pharmaceuticals, Inc.
Treatment for: Schizophrenia

Secuado (asenapine) is a transdermal atypical antipsychotic formulation indicated for the treatment of adults with schizophrenia.

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➡️Amzeeq (minocycline) Topical Foam

Date of Approval: October 18, 2019
Company: Foamix Pharmaceuticals
Treatment for: Acne

Amzeeq (minocycline) is a topical foam formulation of the approved tetracycline drug minocycline indicated for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older.

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➡️Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets

Date of Approval: October 21, 2019
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data.

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➡️Biorphen (phenylephrine hydrochloride) Injection

Date of Approval: October 21, 2019
Company: Eton Pharmaceuticals, Inc.
Treatment for: Hypotension

Biorphen (phenylephrine hydrochloride) injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of hypotension during anesthesia.


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➡️Talicia (amoxicillin, omeprazole and rifabutin) Delayed-Release Capsules

Date of Approval: November 4, 2019
Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter Pylori Infection

Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a fixed-dose combination of two antibiotics, (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) for the treatment of Helicobacter pylori (H. pylori) infection.

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