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New Drug Approvals Archive

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September 2009

September 2

Astepro (azelastine)

New Formulation Approved: August 31, 2009

Astepro (azelastine) FDA Approval History

September 2

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).

Intuniv (guanfacine) FDA Approval History

September 4

Zevalin (ibritumomab tiuxetan)

New Indication Approved: September 3, 2009

September 4

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.

Metozolv ODT (metoclopramide) FDA Approval History

September 8

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.

Bepreve (bepotastine) FDA Approval History

September 11

Vibativ (telavancin) Injection

Date of Approval: September 11, 2009
Company: Theravance Inc.
Treatment for: Complicated Skin and Skin Structure Infections (cSSSI), Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

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.

Vibativ (telavancin) FDA Approval History

September 15

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).

Zirgan (ganciclovir) FDA Approval History

September 15

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.

Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine) FDA Approval History

September 16

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.

Valturna (aliskiren and valsartan) FDA Approval History

September 24

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).

Folotyn (pralatrexate) FDA Approval History

September 25

Stelara (ustekinumab) Injection

Date of Approval: September 25, 2009
Company: Centocor Ortho Biotech Inc.
Treatment for: Psoriasis, Psoriatic Arthritis

Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

Stelara (ustekinumab) FDA Approval History

November 13

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

Patient Population Altered: November 10, 2009
Treatment for: Prevention of H1N1 Influenza

Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine) FDA Approval History

June 21

Vibativ (telavancin)

New Indication Approved: June 21, 2013
Treatment for: Complicated Skin and Skin Structure Infections (cSSSI), Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

Vibativ (telavancin) FDA Approval History

September 23

Stelara (ustekinumab)

New Indication Approved: September 20, 2013

Stelara (ustekinumab) FDA Approval History

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