New Drug Approvals Archive

New Drug Approvals: April 2007

April 12
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%
 
April 13
Risperdal (risperidone)

New Dosage Regimen: April 12, 2007

FDA Approves New Dose of Risperdal Consta for Schizophrenia Treatment
 
April 16
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
 
April 17

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
 
April 27
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
 
April 27
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
 
August 20
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
 
June 5
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
 
June 1
Reclast (zoledronic acid)

New Dosage Regimen: June 1, 2009

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

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