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New Drug Approvals Archive - October 2004

October 2004

October 8

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 (lutropin alfa) FDA Approval History

October 12

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 (histrelin) FDA Approval History

October 13

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 (dermal filler) FDA Approval History

October 18

Aricept (donepezil)

New Dosage Form Approved: October 18, 2004

October 19

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 (fexofenadine and pseudoephedrine) FDA Approval History

October 22

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 (clindamycin phosphate) FDA Approval History

October 26

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 (hyaluronidase) FDA Approval History

October 26

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 (lanthanum carbonate) FDA Approval History

September 24

ProAir HFA (albuterol sulfate)

Patient Population Altered: September 16, 2008

ProAir HFA (albuterol sulfate) FDA Approval History

New Drug Approvals Archive