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New Drug Approvals Archive - July 2009

See also: New Indications and Dosage Forms for July 2009

July 2009

Multaq (dronedarone) Tablets

Date of Approval: July 1, 2009
Company: Sanofi-aventis
Treatment for: Atrial Fibrillation, Atrial Flutter

Multaq (dronedarone) is antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter.

Effient (prasugrel) Tablets

Date of Approval: July 10, 2009
Company: Daiichi Sankyo Company, Limited and Eli Lilly and Company
Treatment for: Acute Coronary Syndrome

Effient (prasugrel) is an oral antiplatelet agent for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention including coronary stenting.

Plan B One-Step (levonorgestrel) Tablet

Date of Approval: July 10, 2009
Company: Teva Pharmaceuticals, Inc.
Treatment for: Emergency Contraception

Plan B One-Step (levonorgestrel) is a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure.

Sumavel DosePro (sumatriptan) Injection

Date of Approval: July 15, 2009
Company: Zogenix, Inc.
Treatment for: Migraine, Cluster Headache

Marketing Status: Discontinued

Sumavel DosePro (sumatriptan injection) is a needle-free delivery system to treat acute migraine (with or without aura), and cluster headache.

Onsolis (fentanyl) Buccal Soluble Film

Date of Approval: July 16, 2009
Company: BioDelivery Sciences International, Inc.
Treatment for: Pain

Marketing Status: Discontinued

Onsolis (fentanyl) is an opioid agonist in a buccal formulation indicated for the management of breakthrough pain in cancer patients.

Acuvail (ketorolac tromethamine) Ophthalmic Solution

Date of Approval: July 22, 2009
Company: Allergan, Inc.
Treatment for: Postoperative Ocular Inflammation

Acuvail (ketorolac tromethamine) is a preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery.

Tyvaso (treprostinil) Inhalation Solution

Date of Approval: July 30, 2009
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension

Tyvaso (treprostinil) is an inhaled prostanoid analogue indicated for the treatment of pulmonary arterial hypertension.

Colcrys (colchicine) Tablets

Date of Approval: July 29, 2009
Company: Mutual Pharmaceutical Company, Inc.
Treatment for: Gout, Familial Mediterranean Fever, Gout -- Prophylaxis, Acute Gout

Colcrys (colchicine) is compound derived from the dried seeds of the autumn crocus or meadow saffron (Colchicum autumnale). Colcrys is approved for the prophylaxis and treatment of acute gout flares, and for the treatment of patients with familial Mediterranean fever.

Onglyza (saxagliptin) Tablets

Date of Approval: July 31, 2009
Company: AstraZeneca
Treatment for: Diabetes Type 2

Onglyza (saxagliptin) is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated for the treatment of type 2 diabetes mellitus in adults.

Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension

Date of Approval: July 31, 2009
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Schizophrenia, Schizoaffective Disorder

Invega Sustenna (1-month paliperidone palmitate) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia and schizoaffective disorder.

Xerese (acyclovir and hydrocortisone) Topical Cream - formerly Lipsovir

Date of Approval: July 31, 2009
Company: Meda Pharmaceuticals Inc.
Treatment for: Herpes Simplex Labialis

Xerese (acyclovir and hydrocortisone) is a topical antiviral and anti-inflammatory combination for the prevention and treatment of cold sores.

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