New Drug Approvals Archive

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July 2012

July 16

Truvada (emtricitabine and tenofovir)

New Indication Approved: July 16, 2012

Truvada (emtricitabine and tenofovir) FDA Approval History

July 16

Prepopik (sodium picosulfate, magnesium oxide and citric acid) for Oral Solution

Date of Approval: July 16, 2012
Company: Ferring Pharmaceuticals
Treatment for: Bowel Preparation

Prepopik (sodium picosulfate, magnesium oxide and citric acid) is a stimulant laxative and osmotic laxative combination indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Prepopik (sodium picosulfate, magnesium oxide and citric acid) FDA Approval History

July 17

Qsymia (phentermine and topiramate) Extended-Release Capsules - formerly Qnexa

Date of Approval: July 17, 2012
Company: Vivus, Inc.
Treatment for: Obesity

Qsymia (phentermine and topiramate) is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate extended-release, an antiepileptic drug, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults.

Qsymia (phentermine and topiramate) FDA Approval History

July 20

Kyprolis (carfilzomib) Injection

Date of Approval: July 20, 2012
Company: Onyx Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma

Kyprolis (carfilzomib) is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma.

Kyprolis (carfilzomib) FDA Approval History

July 20

Afinitor (everolimus)

New Indication Approved: July 20, 2012

Afinitor (everolimus) FDA Approval History

July 23

Tudorza (aclidinium bromide) Pressair

Date of Approval: July 23, 2012
Company: Forest Laboratories, Inc. and Almirall, S.A.
Treatment for: Chronic Obstructive Pulmonary Disease

Tudorza Pressair (aclidinium bromide inhalation powder) is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Tudorza (aclidinium bromide) FDA Approval History

July 26

Vascepa (icosapent ethyl) Capsules

Date of Approval: July 26, 2012
Company: Amarin Corporation plc
Treatment for: Hypertriglyceridemia

Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.

Vascepa (icosapent ethyl) FDA Approval History

July 26

Rayos (prednisone) Delayed-Release Tablets - formerly Lodotra

Date of Approval: July 26, 2012
Company: Horizon Pharma, Inc.
Treatment for: Rheumatoid Arthritis, Polymyalgia Rheumatica, Psoriatic Arthritis, Ankylosing Spondylitis, Asthma, Chronic Obstructive Pulmonary Disease

Rayos (prednisone) is a delayed release corticosteroid indicated as an anti-inflammatory or immunosuppressive agent to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease (COPD).

Rayos (prednisone) FDA Approval History

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