Skip to Content

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

Marketing Status: Discontinued

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

Marketing Status: Discontinued

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, Ulcerative Colitis

Stelara (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of moderate to severe plaque psoriasis (Ps), active psoriatic arthritis (PsA), moderately to severely active Crohn’s disease (CD), and moderately to severely active ulcerative colitis.

New Drug Approvals Archive

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.