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New Drug Approvals Archive - October 2011

October 2011

Cialis (tadalafil)

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.

Read more: Juvisync (simvastatin and sitagliptin) FDA Approval History

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

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 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.

Read more: Exparel (bupivacaine liposome) FDA Approval History

New Drug Approvals Archive