➡️Kynmobi (apomorphine hydrochloride) Sublingual Film

Date of Approval: May 21, 2020
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Parkinson's Disease

Kynmobi (apomorphine sublingual film) is a novel formulation of the approved dopamine agonist apomorphine for the on-demand management of OFF episodes associated with Parkinson’s disease (PD).

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

➡️(artesunate) for Injection

Date of Approval: May 26, 2020
Company: Amivas (US), LLC
Treatment for: Malaria

Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients.

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

➡️Zilxi (minocycline) Topical Foam - formerly FMX103

Date of Approval: May 28, 2020
Company: Foamix Pharmaceuticals Ltd.
Treatment for: Rosacea

Zilxi (minocycline) is a topical tetracycline formulation indicated for the treatment of inflammatory lesions of rosacea in adults.

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

➡️Semglee (insulin glargine-yfgn) Injection

Date of Approval: June 11, 2020
Company: Mylan Pharmaceuticals Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Semglee (insulin glargine-yfgn) is a long-acting human insulin analog biosimilar to Lantus (insulin glargine) indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus.

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➡️Lyumjev (insulin lispro-aabc) Injection

Date of Approval: June 15, 2020
Company: Eli Lilly and Company
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Lyumjev (insulin lispro-aabc) is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

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

➡️Gimoti (metoclopramide) Nasal Spray

Date of Approval: June 19, 2020
Company: Evoke Pharma, Inc.
Treatment for: Gastroparesis

Gimoti (metoclopramide) is an intranasal formulation of the approved drug metoclopramide for the relief of symptoms of acute and recurrent diabetic gastroparesis in adults.

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➡️Fintepla (fenfluramine) Oral Solution

Date of Approval: June 25, 2020
Company: Zogenix, Inc.
Treatment for: Dravet Syndrome, Lennox-Gastaut Syndrome

Fintepla (fenfluramine) is an amphetamine derivative indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.

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➡️Mycapssa (octreotide) Delayed-Release Capsules

Date of Approval: June 26, 2020
Company: Chiasma, Inc.
Treatment for: Acromegaly

Mycapssa (octreotide) is an oral formulation of the approved somatostatin analog octreotide for the treatment of acromegaly.

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

➡️Evrysdi (risdiplam) for Oral Solution

Date of Approval: August 7, 2020
Company: Genentech
Treatment for: Spinal Muscular Atrophy

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

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

➡️Winlevi (clascoterone) Cream

Date of Approval: August 26, 2020
Company: Cassiopea SpA
Treatment for: Acne

Winlevi (clascoterone) cream is a first-in-class topical androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

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➡️Sogroya (somapacitan-beco) Injection

Date of Approval: August 28, 2020
Company: Novo Nordisk
Treatment for: Adult Human Growth Hormone Deficiency

Sogroya (somapacitan-beco) is a human growth hormone analog indicated for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

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➡️Eysuvis (loteprednol etabonate) Ophthalmic Suspension

Date of Approval: October 26, 2020
Company: Kala Pharmaceuticals, Inc.
Treatment for: Dry Eye Disease

Eysuvis (loteprednol etabonate) is an ophthalmic corticosteroid formulation for the temporary relief of signs and symptoms of dry eye disease.

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

➡️Bronchitol (mannitol) Inhalation Powder

Date of Approval: October 30, 2020
Company: Chiesi USA, Inc.
Treatment for: Cystic Fibrosis

Bronchitol (mannitol) is an inhaled dry powder formulation of the sugar alcohol mannitol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis.

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

➡️Sesquient (fosphenytoin sodium) for Injection

Date of Approval: November 5, 2020
Company: Sedor Pharmaceuticals, LLC
Treatment for: Status Epilepticus

Sesquient (fosphenytoin sodium for injection) is a Captisol-enabled™, room-temperature stable formulation of fosphenytoin sodium indicated for the treatment of status epilepticus in adults and children.

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

➡️Oxlumo (lumasiran) Injection

Date of Approval: November 23, 2020
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Primary Hyperoxaluria

Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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➡️Imcivree (setmelanotide) Injection

Date of Approval: November 25, 2020
Company: Rhythm Pharmaceuticals, Inc.
Treatment for: Obesity

Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency; or Bardet-Biedl syndrome.

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➡️Thyquidity (levothyroxine sodium) Oral Solution

Date of Approval: November 30, 2020
Company: Vertice Pharma

Thyquidity (levothyroxine sodium) is a liquid dosage form of levothyroxine for the treatment of hypothyroidism.

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

➡️Orgovyx (relugolix) Tablets

Date of Approval: December 18, 2020
Company: Myovant Sciences
Treatment for: Prostate Cancer

Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

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➡️Gemtesa (vibegron) Tablets

Date of Approval: December 23, 2020
Company: Urovant Sciences
Treatment for: Overactive Bladder

Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency 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.


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

➡️Egaten (triclabendazole) Tablets

Date of Approval: February 13, 2019
Company: Novartis
Treatment for: Fascioliasis

Egaten (triclabendazole) is a benzimidazole anthelmintic indicated for the treatment of fascioliasis, a neglected tropical disease (NTD) caused by liver flukes Fasciola hepatica and Fasciola gigantica.

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