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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: 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, 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: 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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