➡️Jelmyto (mitomycin) for Pyelocalyceal Solution

Date of Approval: April 15, 2020
Company: UroGen Pharma Ltd.
Treatment for: Urothelial Carcinoma

Jelmyto (mitomycin) is a novel formulation of the approved alkylating drug mitomycin for the treatment of patients with low-grade upper tract urothelial cancer (LG-UTUC).

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➡️Tukysa (tucatinib) Tablets

Date of Approval: April 17, 2020
Company: Seattle Genetics, Inc.
Treatment for: Breast Cancer

Tukysa (tucatinib) is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer.

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➡️Ongentys (opicapone) Capsules

Date of Approval: April 24, 2020
Company: Neurocrine Biosciences, Inc.
Treatment for: Parkinson's Disease

Ongentys (opicapone) is a catechol-O-methyltransferase (COMT) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

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➡️Bafiertam (monomethyl fumarate) Delayed-Release Capsules

Date of Approval: April 28, 2020
Company: Banner Life Sciences LLC
Treatment for: Multiple Sclerosis

Bafiertam (monomethyl fumarate) is a novel fumarate indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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➡️Darzalex Faspro (daratumumab and hyaluronidase-fihj) Injection

Date of Approval: May 1, 2020
Company: The Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Multiple Myeloma; Light Chain (AL) Amyloidosis

Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab (a CD38-directed cytolytic antibody) and hyaluronidase (an endoglycosidase) indicated for the treatment of multiple myeloma and light chain (AL) amyloidosis.

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➡️Retevmo (selpercatinib) Capsules

Date of Approval: May 8, 2020
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer

Retevmo (selpercatinib) is a kinase inhibitor for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

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➡️Qinlock (ripretinib) Tablets

Date of Approval: May 15, 2020
Company: Deciphera Pharmaceuticals, Inc.
Treatment for: Gastrointestinal Stromal Tumor

Qinlock (ripretinib) is a broad-spectrum KIT and PDGFRα inhibitor for the treatment of patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

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➡️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).

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➡️(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.

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➡️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.

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➡️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.

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➡️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.

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➡️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.

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➡️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.

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➡️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.

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➡️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.

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