New Drug Approvals Archive - May 2015

Avelox (moxifloxacin)

New Indication Approved: May 8, 2015

• FDA Approves Avelox (moxifloxacin) as Additional Antibacterial Treatment for Plague

Treximet (sumatriptan succinate and naproxen sodium)

Patient Population Altered: May 15, 2015

• FDA Approves Treximet (sumatriptan and naproxen sodium) for Migraine in Pediatric Patients
• Treximet (sumatriptan succinate and naproxen sodium) FDA Approval History

Invega Trinza (paliperidone palmitate) Extended-Release Injectable Suspension

Date of Approval: May 18, 2015
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Schizophrenia

Invega Trinza (3-month paliperidone palmitate) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia.

• FDA Approves Invega Trinza (paliperidone palmitate) Four-Times-A-Year Treatment for Schizophrenia
• Invega Trinza (paliperidone palmitate) FDA Approval History

Stiolto Respimat (olodaterol and tiotropium) Inhalation Spray

Date of Approval: May 21, 2015
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

Stiolto Respimat (olodaterol and tiotropium bromide) is a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) fixed-dose combination for the treatment of chronic obstructive pulmonary disease (COPD).

• FDA Approves Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for COPD
• Stiolto Respimat (olodaterol and tiotropium) FDA Approval History

Viberzi (eluxadoline) Tablets

Date of Approval: May 27, 2015
Company: Allergan, Inc.
Treatment for: Irritable Bowel Syndrome

Viberzi (eluxadoline) is a mu-opioid receptor agonist indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

• FDA Approves Viberzi (eluxadoline) for Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults
• Viberzi (eluxadoline) FDA Approval History

Xifaxan (rifaximin)

New Indication Approved: May 27, 2015

• FDA Approves Xifaxan (rifaximin) for the Treatment of IBS-D (Irritable Bowel Syndrome with Diarrhea)
• Xifaxan (rifaximin) FDA Approval History

Rapamune (sirolimus)

New Indication Approved: May 28, 2015
Treatment for: Lymphangioleiomyomatosis

• FDA Approves Rapamune (sirolimus) for Rare Lung Disease Lymphangioleiomyomatosis