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New Drug Approvals Archive - October 2011

October 2011

October 6

Cialis (tadalafil)

New Indication Approved: October 7, 2011

October 7

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.

Juvisync (simvastatin and sitagliptin) FDA Approval History

October 10

Combivent (albuterol and ipratropium)

New Formulation Approved: October 7, 2011

October 14

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.

Ferriprox (deferiprone) FDA Approval History

October 20

Byetta (exenatide)

New Dosage Regimen: October 19, 2011

Byetta (exenatide) FDA Approval History

October 21

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).

Onfi (clobazam) FDA Approval History

October 28

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.

Exparel (bupivacaine) FDA Approval History

New Drug Approvals Archive