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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, Sickle Cell Anemia

Ferriprox (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in:
  • thalassemia syndromes
  • sickle cell disease or other anemias.
Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age and Ferriprox Oral Solution is indicated in patients ≥3 years of age.

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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