New Drug Approvals Archive - July 2018
See also: New Indications and Dosage Forms for July 2018
July 2018
TPOXX (tecovirimat) Capsules and Injection
Date of Approval: July 13, 2018
Company: SIGA Technologies, Inc.
Treatment for: Smallpox
TPOXX (tecovirimat) is an orthopoxvirus-specific antiviral indicated for the treatment of human smallpox disease.
Symtuza (cobicistat, darunavir, emtricitabine and tenofovir alafenamide) Tablets
Date of Approval: July 17, 2018
Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection
Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide) is a once daily, single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.
Tibsovo (ivosidenib) Tablets
Date of Approval: July 20, 2018
Company: Servier Pharmaceuticals
Treatment for: Acute Myeloid Leukemia, Cholangiocarcinoma of Biliary Tract
Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor used in the treatment of patients with IDH1-mutated acute myeloid leukemia (AML) and IDH1-mutated cholangiocarcinoma.
Nivestym (filgrastim-aafi) Injection
Date of Approval: July 20, 2018
Company: Pfizer Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Febrile Neutropenia
Nivestym (filgrastim-aafi) is a recombinant human granulocyte colony-stimulating factor biosimilar to Neupogen indicated for the treatment of neutropenia associated with chemotherapy and related conditions.
Krintafel (tafenoquine) Tablets
Date of Approval: July 20, 2018
Company: GlaxoSmithKline
Treatment for: Malaria
Krintafel (tafenoquine) is an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria.
Orilissa (elagolix) Tablets
Date of Approval: July 23, 2018
Company: AbbVie, Inc.
Treatment for: Endometriosis
Orilissa (elagolix) is an orally administered gonadotropin-releasing hormone (GnRH) antagonist for the management of moderate to severe pain associated with endometriosis.
Perseris (risperidone) for Extended-Release Injectable Suspension
Date of Approval: July 27, 2018
Company: Indivior PLC
Treatment for: Schizophrenia
Perseris (risperidone) is a once-monthly, subcutaneous formulation of the approved atypical antipsychotic risperidone indicated for the treatment of schizophrenia in adults.
Azedra (iobenguane I 131) Injection
Date of Approval: July 30, 2018
Company: Progenics Pharmaceuticals Inc.
Treatment for: Pheochromocytoma; Paraganglioma
Azedra (iobenguane I 131) is a radioactive therapeutic agent for the treatment of locally advanced or metastatic pheochromocytoma and paraganglioma.
Mulpleta (lusutrombopag) Tablets
Date of Approval: July 31, 2018
Company: Shionogi Inc.
Treatment for: Thrombocytopenia
Mulpleta (lusutrombopag) is a once-daily, orally administered, thrombopoietin (TPO) receptor agonist for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical or dental procedure.
New drug approvals archive
- 2022
- January, February, March, April, May, June
- 2021
- January, February, March, April, May, June, July, August, September, October, November, December
- 2020
- January, February, March, April, May, June, July, August, September, October, November, December
- 2019
- January, February, March, April, May, June, July, August, September, October, November, December
- 2018
- January, February, March, April, May, June, July, August, September, October, November, December
- 2017
- January, February, March, April, May, June, July, August, September, October, November, December
- 2016
- January, February, March, April, May, June, July, August, September, October, November, December
- 2015
- January, February, March, April, May, June, July, August, September, October, November, December
- 2014
- January, February, March, April, May, June, July, August, September, October, November, December
- 2013
- January, February, March, April, May, June, July, August, September, October, November, December
- 2012
- January, February, March, April, May, June, July, August, September, October, November, December
- 2011
- January, February, March, April, May, June, July, August, October, November, December
- 2010
- January, February, March, April, May, June, July, August, September, October, November, December
- 2009
- January, February, March, April, May, June, July, August, September, October, November, December
- 2008
- January, February, March, April, May, June, July, August, September, October, November, December
- 2007
- January, February, March, April, May, June, July, August, September, October, November, December
- 2006
- January, February, March, April, May, June, July, August, September, October, November, December
- 2005
- January, February, March, April, May, June, July, August, September, October, November, December
- 2004
- January, February, March, April, May, June, July, August, September, October, November, December
- 2003
- January, February, March, April, May, June, July, August, September, October, November, December
- 2002
- January, February, April, May, July, August, October, November, December
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.