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