New Drug Approvals Archive - August 2013
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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 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: 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.
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