New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

April 2007

April 2

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

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

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

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.

Altabax (retapamulin) FDA Approval History

April 13

Risperdal (risperidone)

New Dosage Regimen: April 12, 2007

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 (zoledronic acid) FDA Approval History

April 17

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."

Influenza Virus Vaccine, H5N1 FDA Approval History

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.

Veramyst (fluticasone furoate) FDA Approval History

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.

AzaSite (azithromycin) FDA Approval History

April 30

Enjuvia (synthetic conjugated estrogens, B)

New Indication Approved: April 23, 2007

Enjuvia (synthetic conjugated estrogens, B) FDA Approval History

August 20

Reclast (zoledronic acid)

New Indication Approved: August 17, 2007

Reclast (zoledronic acid) FDA Approval History

June 5

Reclast (zoledronic acid)

New Indication Approved: June 3, 2008

Reclast (zoledronic acid) FDA Approval History

June 1

Reclast (zoledronic acid)

New Dosage Regimen: June 1, 2009

Reclast (zoledronic acid) FDA Approval History

November 22

Influenza Virus Vaccine, H5N1 ()

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

Influenza Virus Vaccine, H5N1 FDA Approval History

Hide
(web4)