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New Drug Approvals Archive - October 2011

See also: New Indications and Dosage Forms for October 2011

October 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

Marketing Status: Discontinued

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.

Ferriprox (deferiprone) Tablets and Oral Solution

Date of Approval: October 14, 2011
Company: ApoPharma Inc.
Treatment for: Thalassemia, Iron Overload

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.

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).

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.

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