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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)

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) Powder for Oral Solution

Date of Approval: August 13, 2013
Company: Silvergate Pharmaceuticals Inc.
Treatment for: Hypertension

Epaned (enalapril) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month.

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.

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