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New Drug Approvals Archive - September 2009

See also: New Indications and Dosage Forms for September 2009

September 2009

Intuniv (guanfacine) Extended Release Tablets - formerly Connexyn

Date of Approval: September 2, 2009
Company: Shire plc
Treatment for: Attention-Deficit Hyperactivity Disorder

Intuniv (guanfacine) is a nonstimulant selective alpha-2A-receptor agonist for the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

Metozolv ODT (metoclopramide) Orally Disintegrating Tablets

Date of Approval: September 4, 2009
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Gastroesophageal Reflux Disease, Gastroparesis

Metozolv ODT is a fast–dissolving formulation of metoclopramide for the short–term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.

Bepreve (bepotastine) Ophthalmic Solution

Date of Approval: September 8, 2009
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Allergic Conjunctivitis

Bepreve (bepotastine ophthalmic solution) is an antihistamine and mast cell stabilizer for treatment of the symptoms of allergic conjunctivitis.

Vibativ (telavancin) Injection

Date of Approval: September 11, 2009
Company: Theravance Inc.
Treatment for: Skin and Structure Infection, Pneumonia

Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI), and hospital-acquired and ventilator-associated bacterial pneumonia.

Zirgan (ganciclovir) Ophthalmic Gel

Date of Approval: September 15, 2009
Company: Sirion Therapeutics, Inc.
Treatment for: Herpetic Keratitis

Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers).

Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine)

Date of Approval: September 15, 2009
Company: CSL Limited; Novartis Vaccines and Diagnostics Limited; Sanofi Pasteur, Inc.; MedImmune LLC
Treatment for: Prevention of H1N1 Influenza

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

Valturna (aliskiren and valsartan) Tablets

Date of Approval: September 16, 2009
Company: Novartis
Treatment for: Hypertension

Valturna is a combination of aliskiren (a direct renin inhibitor) and valsartan (an angiotensin II receptor blocker) indicated for the treatment of high blood pressure.

Folotyn (pralatrexate) Injection

Date of Approval: September 24, 2009
Company: Allos Therapeutics, Inc.
Treatment for: Peripheral T-cell Lymphoma

Folotyn (pralatrexate) is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Stelara (ustekinumab) Injection

Date of Approval: September 25, 2009
Company: Janssen Biotech, Inc.
Treatment for: Psoriasis, Psoriatic Arthritis, Crohn's Disease -- Maintenance

Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease.

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