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New Drug Approvals Archive - August 2019

See also: New Indications and Dosage Forms for August 2019

August 2019

Turalio (pexidartinib) Capsules

Date of Approval: August 2, 2019
Company: Daiichi Sankyo Company, Limited
Treatment for: Tenosynovial Giant Cell Tumor

Turalio (pexidartinib) is a kinase inhibitor indicated for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adults.

(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).

Rozlytrek (entrectinib) Capsules

Date of Approval: August 15, 2019
Company: Genentech, Inc.
Treatment for: Solid Tumors, Non-Small Cell Lung Cancer

Rozlytrek (entrectinib) is a selective tyrosine kinase inhibitor for the treatment of patients with ROS1-positive, metastatic non-small cell lung cancer and neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumors.

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.

Inrebic (fedratinib) Capsules

Date of Approval: August 16, 2019
Company: Celgene Corporation
Treatment for: Myelofibrosis

Inrebic (fedratinib) is a highly selective JAK2 inhibitor for the treatment of patients with myelofibrosis.

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.

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).

Nourianz (istradefylline) Tablets

Date of Approval: August 27, 2019
Company: Kyowa Kirin, Inc.
Treatment for: Parkinson's Disease

Nourianz (istradefylline) is an adenosine A2A receptor antagonist indicated for use as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes.

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