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New Drug Approvals Archive

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August 2013

August 2

Menveo (meningococcal conjugate vaccine)

Patient Population Altered: August 2, 2013

Menveo (meningococcal conjugate vaccine) FDA Approval History

August 12

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.

Tivicay (dolutegravir) FDA Approval History

August 13

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.

Epaned (enalapril) FDA Approval History

August 16

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.

Trokendi XR (topiramate) FDA Approval History

August 23

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.

Valchlor (mechlorethamine) FDA Approval History

August 23

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.

Mirvaso (brimonidine) FDA Approval History

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