New Drug Approvals Archive - 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 duration of febrile neutropenia in patients treated with chemotherapy.

• U.S. FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta
• Fulphila (pegfilgrastim-jmdb) FDA Approval History

Mircera (epoetin beta-methoxy polyethylene glycol)

Patient Population Altered: June 7, 2018

• FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
• Mircera (epoetin beta-methoxy polyethylene glycol) FDA Approval History

Rituxan (rituximab)

New Indication Approved: June 7, 2018

• FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris

Venclexta (venetoclax)

New Indication Approved: June 8, 2018

• Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia
• Venclexta (venetoclax) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: June 12, 2018

• FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1
• Keytruda (pembrolizumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: June 13, 2018

• FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
• Keytruda (pembrolizumab) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: June 13, 2018

• FDA Approves Genentech’s Avastin (bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery
• Avastin (bevacizumab) FDA Approval History

(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.

• FDA Approves Moxidectin for the Treatment of River Blindness
• moxidectin FDA Approval History

Cinryze (C1 esterase inhibitor (human))

Patient Population Altered: June 20, 2018

• Shire Announces FDA Approval for Label Expansion of Cinryze (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients
• Cinryze (C1 esterase inhibitor (human)) FDA Approval History

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.

• Nocdurna (desmopressin acetate) Approved by FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria
• Nocdurna (desmopressin acetate) FDA Approval History

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.

• FDA Approves Epidiolex (cannabidiol) to Treat Lennox-Gastaut Syndrome and Dravet Syndrome
• Epidiolex (cannabidiol) FDA Approval History

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.

• Zemdri (plazomicin) Approved by FDA for the Treatment of Adults with Complicated Urinary Tract Infections (cUTI)
• Zemdri (plazomicin) FDA Approval History

Braftovi (encorafenib) Capsules

Date of Approval: June 27, 2018
Company: Array BioPharma Inc.
Treatment for: Melanoma - Metastatic

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.

• Array BioPharma Announces FDA Approval of Braftovi (encorafenib) in Combination with Mektovi (binimetinib) for Unresectable or Metastatic Melanoma with BRAF Mutations
• Braftovi (encorafenib) FDA Approval History

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.

• FDA Approves Mektovi (binimetinib) and Braftovi (encorafenib) in Combination for Unresectable or Metastatic Melanoma with BRAF Mutations
• Mektovi (binimetinib) FDA Approval History

Nuplazid (pimavanserin)

New Dosage Form Approved: June 29, 2018
Treatment for: Parkinson’s Disease Psychosis

• Acadia Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for Nuplazid (pimavanserin)
• Nuplazid (pimavanserin) FDA Approval History

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.

• Dermira Receives FDA Approval for Qbrexza (glycopyrronium) Cloth to Treat Excessive Underarm Sweating
• Qbrexza (glycopyrronium) FDA Approval History