New Drug Approvals Archive - October 2004

Luveris (lutropin alfa) for Injection

Date of Approval: October 8, 2004
Company: Serono, Inc.
Treatment for: Female Infertility

Luveris (lutropin alfa) is a recombinant human form of luteinizing hormone indicated for use in combination with follitropin alfa for the stimulation of follicular development in infertile women.

• Luveris Serono, Inc. - Treatment for Infertility

Luveris (lutropin alfa) FDA Approval History

Vantas (histrelin) Implant

Date of Approval: October 12, 2004
Company: Valera Pharmaceuticals
Treatment for: Prostate Cancer

Vantas (histrelin) implant is an LHRH agonist administered once-yearly for the palliative treatment of advanced prostate cancer.

• Vantas Valera Pharmaceuticals - Treatment for Prostate Cancer

Vantas (histrelin) FDA Approval History

Hylaform Plus (dermal filler)

Date of Approval: October 13, 2004
Company: Inamed Corporation and Genzyme Corporation
Treatment for: Wrinkle Correction

Hylaform Plus is a large particle size hyaluronic acid-based dermal filler that is indicated for the correction of moderate to severe facial wrinkles and folds.

• Hylaform Plus Inamed Corporation and Genzyme Corporation - Treatment for Wrinkle Correction

Hylaform Plus (dermal filler) FDA Approval History

Aricept (donepezil)

New Dosage Form Approved: October 18, 2004

• Aricept ODT Eisai Inc. - Treatment for Alzheimer’s Disease

Allegra-D 24 Hour (fexofenadine and pseudoephedrine)

Date of Approval: October 19, 2004
Company: Sanofi Aventis US
Treatment for: Allergic Rhinitis, Nasal Congestion

Allegra-D 24 Hour (fexofenadine and pseudoephedrine) is a once daily prescription antihistamine and decongestant formulation approved for the treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older.

• Allegra-D 24 Hour Aventis Pharmaceuticals Inc. - Treatment for Seasonal Allergy Symptoms with Nasal Congestion

Allegra-D 24 Hour (fexofenadine and pseudoephedrine) FDA Approval History

Evoclin (clindamycin phosphate) Foam - formerly Actiza

Date of Approval: October 22, 2004
Company: Connetics Corporation
Treatment for: Acne

Evoclin (clindamycin) is a topical antibiotic indicated for the treatment of acne vulgaris.

• Evoclin Connetics Corporation - Treatment for Acne

Evoclin (clindamycin phosphate) FDA Approval History

Amphadase (hyaluronidase) Injection

Date of Approval: October 26, 2004
Company: Amphastar Pharmaceuticals, Inc
Treatment for: Adjuvant to increase the absorption and dispersion of other injected drugs

Amphadase (hyaluronidase) used as an adjunctive agent to facilitate the dispersion and absorption of other drugs.

• Amphadase Amphastar Pharmaceuticals, Inc - Treatment for Adjunctive Agent

Amphadase (hyaluronidase) FDA Approval History

Fosrenol (lanthanum carbonate) Chewable Tablets

Date of Approval: October 26, 2004
Company: Shire Pharmaceuticals Group plc
Treatment for: Hyperphosphatemia of Renal Failure

Fosrenol is a phosphate binder used to reduce high phosphorus levels in end-stage renal disease (ESRD) patients.

• Fosrenol Shire Pharmaceuticals Group plc - Treatment for Hyperphosphataemia in ESRD Patients

Fosrenol (lanthanum carbonate) FDA Approval History

ProAir HFA (albuterol sulfate)

Patient Population Altered: September 16, 2008

• Teva's ProAir HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication

ProAir HFA (albuterol sulfate) FDA Approval History