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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

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: Lennox-Gastaut Syndrome, Dravet Syndrome

Epidiolex (cannabidiol) is a prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older.

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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