New Drug Approvals Archive - October 2011
New Indication Approved: October 7, 2011
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.
Combivent (albuterol and ipratropium)
New Formulation Approved: October 7, 2011
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.
Read more: Ferriprox (deferiprone) FDA Approval History
New Dosage Regimen: October 19, 2011
Read more: 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).
Read more: Onfi (clobazam) FDA Approval History
Exparel (bupivacaine) 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 the management of postsurgical pain.
- Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel For Postsurgical Pain Management
Read more: Exparel (bupivacaine) FDA Approval History