New Drug Approvals Archive

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 Schizophrenia Treatment

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
Company: Sanofi Pasteur Inc.
Treatment for: Prevention of H5N1 Influenza (Avian Influenza)

Influenza Virus Vaccine, H5N1 is an inactivated influenza virus vaccine indicated for immunization of persons 18 through 64 years of age who are at increased risk of exposure to the 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 Spray for Treatment of Seasonal and Year-Round Allergy Symptoms in Adults and 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) Tablets Receives 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