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

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

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

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)

New Indication Approved: June 13, 2018

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

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

(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