New Drug Approvals Archive - July 2012

Truvada (emtricitabine and tenofovir)

New Indication Approved: July 16, 2012

• FDA Approves Truvada for Reducing the Risk of Sexually Acquired HIV Infection
• Truvada (emtricitabine and tenofovir) FDA Approval History

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.

• FDA Approves Prepopik for Colonoscopy Prep
• Prepopik (sodium picosulfate, magnesium oxide and citric acid) FDA Approval History

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.

• FDA Approves Weight-Management Drug Qsymia
• Qsymia (phentermine and topiramate) FDA Approval History

Kyprolis (carfilzomib) Injection

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

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

• FDA Approves Kyprolis for Patients with Advanced Multiple Myeloma
• Kyprolis (carfilzomib) FDA Approval History

Afinitor (everolimus)

New Indication Approved: July 20, 2012

• FDA Approves Afinitor for Advanced Breast Cancer
• Afinitor (everolimus) FDA Approval History

Tudorza (aclidinium bromide) Pressair

Date of Approval: July 23, 2012
Company: Allergan, Inc.
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.

• FDA Approves Tudorza Pressair to Treat Chronic Obstructive Pulmonary Disease
• Tudorza (aclidinium bromide) FDA Approval History

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.

• Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia
• Vascepa (icosapent ethyl) FDA Approval History

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).

• Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications
• Rayos (prednisone) FDA Approval History

Kyprolis (carfilzomib)

New Indication Approved: July 24, 2015

• FDA Approves Kyprolis (carfilzomib) for Combination Treatment of Patients with Relapsed Multiple Myeloma
• Kyprolis (carfilzomib) FDA Approval History

Kyprolis (carfilzomib)

New Indication Approved: January 21, 2016

• FDA Approves New Kyprolis (Carfilzomib) Combination Therapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
• Kyprolis (carfilzomib) FDA Approval History