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 | 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 |
| 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 |
New Drug Approvals Archive
2009: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Feb | Jul | Aug | Oct | Nov | Dec
