New Drug Approvals Archive - June 2018
See also: New Indications and Dosage Forms for June 2018
June 2018
Fulphila (pegfilgrastim-jmdb) Injection
Date of Approval: June 4, 2018
Company: Mylan N.V.
Treatment for: Neutropenia Associated with Chemotherapy
Fulphila (pegfilgrastim-jmbd) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.
(moxidectin) Tablets
Date of Approval: June 13, 2018
Company: Medicines Development for Global Health
Treatment for: Onchocerciasis, River Blindness
Moxidectin is a macrocyclic lactone anthelmintic medicine indicated for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older.
Nocdurna (desmopressin acetate) Sublingual Tablets
Date of Approval: June 21, 2018
Company: Ferring Pharmaceuticals Inc.
Treatment for: Nocturia
Nocdurna (desmopressin acetate) is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults.
Epidiolex (cannabidiol) Oral Solution
Date of Approval: June 25, 2018
Company: GW Pharmaceuticals plc
Treatment for: Seizures associated with Lennox-Gastaut Syndrome, Dravet syndrome, or Tuberous Sclerosis Complex
Epidiolex (cannabidiol) is a prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.
Zemdri (plazomicin) Injection
Date of Approval: June 25, 2018
Company: Achaogen, Inc.
Treatment for: Urinary Tract Infection
Zemdri (plazomicin) is an aminoglycoside antibacterial for the treatment of complicated urinary tract infections.
Braftovi (encorafenib) Capsules
Date of Approval: June 27, 2018
Company: Pfizer, Inc.
Treatment for: Melanoma, Metastatic, Colorectal Cancer
Braftovi (encorafenib) is a kinase inhibitor indicated:
- in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
- in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Mektovi (binimetinib) Tablets
Date of Approval: June 27, 2018
Company: Array BioPharma Inc.
Treatment for: Melanoma, Metastatic
Mektovi (binimetinib) is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Qbrexza (glycopyrronium) Cloth for Topical Use
Date of Approval: June 28, 2018
Company: Dermira, Inc.
Treatment for: Hyperhidrosis
Qbrexza (glycopyrronium) is a topical anticholinergic contained in a single-use, pre-moistened, medicated cloth for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older.
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