New Drug Approvals Archive - October 2011

Cialis (tadalafil)

New Indication Approved: October 7, 2011

• FDA Approves Cialis to Treat Benign Prostatic Hyperplasia

Juvisync (simvastatin and sitagliptin) Tablets

Date of Approval: October 7, 2011
Company: Merck & Co., Inc.
Treatment for: Diabetes Type 2, Homozygous Familial Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia, Hypertriglyceridemia

Juvisync (simvastatin and sitagliptin) is an HMG-CoA reductase inhibitor (statin) and dipeptidyl peptidase-4 (DPP-4) inhibitor fixed dose combination for the treatment of high cholesterol and type 2 diabetes.

• FDA Approves Combination Therapy Juvisync
• Juvisync (simvastatin and sitagliptin) FDA Approval History

Combivent (albuterol and ipratropium)

New Formulation Approved: October 7, 2011

• FDA Approves Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease

Ferriprox (deferiprone) Tablets

Date of Approval: October 14, 2011
Company: ApoPharma Inc.
Treatment for: Hemosiderosis

Ferriprox (deferiprone) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

• FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
• Ferriprox (deferiprone) FDA Approval History

Byetta (exenatide)

New Dosage Regimen: October 19, 2011

• Byetta Approved for Use with Insulin Glargine in the U.S.
• Byetta (exenatide) FDA Approval History

Onfi (clobazam) Tablets

Date of Approval: October 21, 2011
Company: Lundbeck Inc.
Treatment for: Lennox-Gastaut Syndrome

Onfi (clobazam) is a benzodiazepine antiepileptic drug for the treatment of patients with Lennox-Gastaut syndrome (LGS).

• FDA Approves Onfi for Seizures Associated with Lennox-Gastaut Syndrome
• Onfi (clobazam) FDA Approval History

Exparel (bupivacaine liposome) Injectable Suspension

Date of Approval: October 28, 2011
Company: Pacira Pharmaceuticals, Inc.
Treatment for: Pain

Exparel (bupivacaine liposome injectable suspension) is a long-acting non-opioid local analgesic for postsurgical local analgesia, and for use as a nerve block (interscalene brachial plexus block) to provide pain relief following shoulder surgeries.

• Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel For Postsurgical Pain Management
• Exparel (bupivacaine liposome) FDA Approval History

Exparel (bupivacaine liposome)

New Indication Approved: April 6, 2018

• Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia
• Exparel (bupivacaine liposome) FDA Approval History