New Drug Approvals Archive - September 2009

Astepro (azelastine)

New Formulation Approved: August 31, 2009

• Meda Receives FDA Approval of New Astepro (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine

Astepro (azelastine) FDA Approval History

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).

• Shire Announces FDA Approval of Once-Daily Intuniv (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17

Intuniv (guanfacine) FDA Approval History

Zevalin (ibritumomab tiuxetan)

New Indication Approved: September 3, 2009

• FDA Approves Zevalin Expanded Label as Part of First-Line Therapy in Treatment of Follicular Non-Hodgkin's Lymphoma

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.

• Salix Receives FDA Marketing Approval for Metozolv ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD

Metozolv ODT (metoclopramide) FDA Approval History

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.

• Ista Pharmaceuticals' Bepreve Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies

Bepreve (bepotastine) FDA Approval History

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.

• Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections

Vibativ (telavancin) FDA Approval History

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).

• Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis

Zirgan (ganciclovir) FDA Approval History

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.

• FDA Approves Vaccines for 2009 H1N1 Influenza Virus

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

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.

• Novartis receives FDA approval for Valturna, a single-pill combination of valsartan and aliskiren, to treat high blood pressure

Valturna (aliskiren and valsartan) FDA Approval History

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).

• FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma

Folotyn (pralatrexate) FDA Approval History

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.

• FDA Approves Stelara (ustekinumab) to Treat Psoriasis

Stelara (ustekinumab) FDA Approval History

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

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

• FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

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

Vibativ (telavancin)

New Indication Approved: June 21, 2013

• FDA Approves Vibativ for Hospitalized Patients with Bacterial Pneumonia

Vibativ (telavancin) FDA Approval History

Stelara (ustekinumab)

New Indication Approved: September 20, 2013

• Stelara (ustekinumab) Receives FDA Approval to Treat Active Psoriatic Arthritis

Stelara (ustekinumab) FDA Approval History

Vibativ (telavancin)

Labeling Revision Approved: May 6, 2016

• Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin)

Vibativ (telavancin) FDA Approval History

Stelara (ustekinumab)

New Indication Approved: September 23, 2016

• FDA Approves Stelara (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn's Disease

Stelara (ustekinumab) FDA Approval History