New Drug Approvals Archive - April 2007

Rhophylac (Rh0(D) immune globulin intravenous (human))

New Indication Approved: March 16, 2007
Treatment for: Prevention of Rho(D) Sensitization

• FDA Approves Rhophylac for the Treatment of Immune Thrombocytopenic Purpura (ITP)

Rhophylac (Rh0(D) immune globulin intravenous (human)) FDA Approval History

Altabax (retapamulin) Ointment

Date of Approval: April 12, 2007
Company: GlaxoSmithKline
Treatment for: Impetigo

Altabax (retapamulin) is a topical antibiotic indicated for the treatment of impetigo in adults and children aged 9 months and older.

• GSK Announces FDA Approval of Altabax (Retapamulin Ointment), 1%

Altabax (retapamulin) FDA Approval History

Risperdal (risperidone)

New Dosage Regimen: April 12, 2007

• FDA Approves New Dose of Risperdal Consta for SchizophreniaTreatment

Reclast (zoledronic acid) Injection - formerly Aclasta

Date of Approval: April 16, 2007
Company: Novartis
Treatment for: Paget's Disease, Prevention of Osteoporosis, Prevention of Fractures

Reclast (zoledronic acid) is a bisphosphonate indicated for the treatment for Paget's disease, postmenopausal osteoporosis and prevention of fractures.

• Reclast Receives US Approval as a Highly Effective Treatment for Patients with Paget's Disease of the Bone

Reclast (zoledronic acid) FDA Approval History

Influenza Virus Vaccine, H5N1 () Injection

Date of Approval: April 17, 2007
Treatment for: Prevention of H5N1 Influenza (Avian Influenza)

Influenza Virus Vaccine, H5N1 is a vaccine indicated for the prevention of H5N1 influenza virus, commonly referred to as avian influenza or "bird flu."

• FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1

Influenza Virus Vaccine, H5N1 FDA Approval History

Veramyst (fluticasone furoate) Nasal Spray

Date of Approval: April 27, 2007
Company: GlaxoSmithKline
Treatment for: Allergic Rhinitis

Veramyst (fluticasone furoate) is an intranasal corticosteroid administered once-daily for the treatment of seasonal and year- round allergy symptoms in adults and children two years of age and older.

• FDA Approves Once-Daily Veramyst (fluticasone furoate) Nasal Sprayfor Treatment of Seasonal and Year-Round Allergy Symptoms in Adultsand Children as Young as Two Years

Veramyst (fluticasone furoate) FDA Approval History

AzaSite (azithromycin) Ophthalmic Solution

Date of Approval: April 27, 2007
Company: InSite Vision Incorporated
Treatment for: Bacterial Conjunctivitis

AzaSite is an ophthalmic formulation of the well-known, broad-spectrum antibiotic azithromycin indicated for the treatment of bacterial conjunctivitis.

• Inspire Announces FDA Approval Of AzaSite

AzaSite (azithromycin) FDA Approval History

Enjuvia (synthetic conjugated estrogens, B)

New Indication Approved: April 23, 2007

• Duramed's Enjuvia (Synthetic Conjugated Estrogens, B) TabletsReceives Two New FDA Approvals

Enjuvia (synthetic conjugated estrogens, B) FDA Approval History

Reclast (zoledronic acid)

New Indication Approved: August 17, 2007

• Reclast Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis

Reclast (zoledronic acid) FDA Approval History

Reclast (zoledronic acid)

New Indication Approved: June 3, 2008

• FDA broadens US indication for once-yearly Reclast as only osteoporosis treatment approved for prevention of fractures after a hip fracture

Reclast (zoledronic acid) FDA Approval History

Reclast (zoledronic acid)

New Dosage Regimen: June 1, 2009

• FDA Approves Reclast to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing

Reclast (zoledronic acid) FDA Approval History

Influenza Virus Vaccine, H5N1 ()

New Formulation Approved: November 22, 2013
Treatment for: Prevention of H5N1 Influenza (Avian Influenza)

• FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza

Influenza Virus Vaccine, H5N1 FDA Approval History