New Drug Approvals Archive - 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.

• FDA Approves FluLaval for Upcoming Influenza Season

FluLaval Quadrivalent (influenza virus vaccine) FDA Approval History

Menveo (meningococcal conjugate vaccine)

Patient Population Altered: August 2, 2013

• FDA Expands Age Indication for Menveo

Menveo (meningococcal conjugate vaccine) FDA Approval History

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.

• FDA Approves Tivicay (dolutegravir) to Treat HIV Infection

Tivicay (dolutegravir) FDA Approval History

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.

• FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults

Epaned (enalapril) FDA Approval History

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.

• FDA Approves FluLaval Quadrivalent

FluLaval Quadrivalent (influenza virus vaccine) FDA Approval History

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.

• Supernus Announces Final FDA Approval and Upcoming Launch of Trokendi XR

Trokendi XR (topiramate) FDA Approval History

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.

• Ceptaris Receives FDA Approval for Valchlor (mechlorethamine) Gel for the Treatment of Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma

Valchlor (mechlorethamine) FDA Approval History

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.

• Galderma Receives FDA Approval of Mirvaso for the Topical Treatment of Facial Erythema of Rosacea

Mirvaso (brimonidine) FDA Approval History

FluLaval Quadrivalent (influenza virus vaccine)

Patient Population Altered: November 18, 2016

• GSK Receives FDA Approval for Expanded Indication for FluLaval Quadrivalent (Influenza Vaccine) for Infants 6 Months and Older

FluLaval Quadrivalent (influenza virus vaccine) FDA Approval History