New Drug Approvals Archive - August 2013
Get news by email or subscribe to our news feeds.
See also: New Indications and Dosage Forms for August 2013
August 2013
FluLaval Quadrivalent (influenza virus vaccine)
Date of Approval: August 16, 2013
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis
FluLaval Quadrivalent (influenza virus vaccine) is a vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Tivicay (dolutegravir) Tablets
Date of Approval: August 12, 2013
Company: ViiV Healthcare
Treatment for: HIV Infection
Tivicay (dolutegravir) is an integrase inhibitor 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: Hypertension, Congestive 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)
Date of Approval: August 16, 2013
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis
FluLaval Quadrivalent (influenza virus vaccine) is a vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
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: Acne 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: Hypertension, Congestive 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: Hypertension, Congestive 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
2019January, February, March, April, May, June, July, August, September
2018January, February, March, April, May, June, July, August, September, October, November, December
2017January, February, March, April, May, June, July, August, September, October, November, December
2016January, February, March, April, May, June, July, August, September, October, November, December
2015January, February, March, April, May, June, July, August, September, October, November, December
2014January, February, March, April, May, June, July, August, September, October, November, December
2013January, February, March, April, May, June, July, August, September, October, November, December
2012January, February, March, April, May, June, July, August, September, October, November, December
2011January, February, March, April, May, June, July, August, October, November, December
2010January, February, March, April, May, June, July, August, September, October, November, December
2009January, February, March, April, May, June, July, August, September, October, November, December
2008January, February, March, April, May, June, July, August, September, October, November, December
2007January, February, March, April, May, June, July, August, September, October, November, December
2006January, February, March, April, May, June, July, August, September, October, November, December
2005January, February, March, April, May, June, July, August, September, October, November, December
2004January, February, March, April, May, June, July, August, September, October, November, December
2003January, February, March, April, May, June, July, August, September, October, November, December
2002January, 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
- Monthly Update Archive
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
