New Drug Approvals Archive - August 2013
See also: New Indications and Dosage Forms for August 2013
August 2013
FluLaval Quadrivalent (influenza virus vaccine, inactivated)
Date of Approval: August 16, 2013
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis
FluLaval Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in people aged 6 months and older.
Tivicay (dolutegravir) Tablets
Date of Approval: August 12, 2013
Company: ViiV Healthcare
Treatment for: HIV Infection
Tivicay (dolutegravir) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1.
Epaned (enalapril maleate) Oral Solution
Date of Approval: August 13, 2013
Company: Silvergate Pharmaceuticals Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction
Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.
FluLaval Quadrivalent (influenza virus vaccine, inactivated)
Date of Approval: August 16, 2013
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis
FluLaval Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in people aged 6 months and older.
Trokendi XR (topiramate)
Date of Approval: August 16, 2013
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Epilepsy
Trokendi XR (topiramate) is an antiepileptic drug indicated for the treatment of epilepsy.
Valchlor (mechlorethamine) Topical Gel
Date of Approval: August 23, 2013
Company: Ceptaris Therapeutics, Inc.
Treatment for: Mycosis Fungoides
Valchlor (mechlorethamine) gel an alkylating agent indicated for the topical treatment of Stage IA and IB mycosis fungoides‐type cutaneous T‐cell lymphoma.
Mirvaso (brimonidine) Topical Gel
Date of Approval: August 23, 2013
Company: Galderma Laboratories, L.P.
Treatment for: Rosacea
Mirvaso (brimonidine) topical gel is an alpha adrenergic agonist indicated for the topical treatment of facial erythema of rosacea.
Epaned (enalapril maleate) Oral Solution
Date of Approval: August 13, 2013
Company: Silvergate Pharmaceuticals Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction
Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.
Epaned (enalapril maleate) Oral Solution
Date of Approval: August 13, 2013
Company: Silvergate Pharmaceuticals Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction
Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.
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.