|
Class |
Name/Company |
Approval Dates and Comments |
|
Antibacterial
|
Mupirocin
Bactroban®
SmithKline Beecham
|
The United States FDA approved the addition of pediatric indications, including topical treatment of impetigo.
|
|
Anti-acne
|
Roxithromycin
Rulid®
Hoechst Marion Roussel
|
Approved by Japanese drug regulatory authority for treatment of severe acne. Rulid was first launched in 1991, and has numerous other indications.
|
|
Anticancer
|
Temoporfin
Foscan®
Scotia
|
The United States FDA designated priority review in March, 1999, to this photodynamic therapy for the palliative treatment of recurrent, refractory or second primary squamous cell carcinomas of the head and neck in patients considered to be incurable with surgery or radiotherapy. Scotia hopes to file an NDA for this product by the end of September, 1999.
|
|
Anti-inflammatory
|
Fluticasone propionate
Cutivate® Cream
Glaxo Wellcome
|
HPB Ottawa approved for the treatment of atopic dermatitis in infants three months of age or older.
|
|
Vaginal preparation
|
17-Beta-Estradiol
Vagifem®
Novo Nordisk
|
The United States FDA has approved this vaginal tablet insert for treatment of atrophic vaginitis. There are a number of contraindications, including known/suspected breast carcinoma, estrogen-dependent neoplasia, pregnancy, abnormal genital bleeding, porphyria, thrombophlebitis or thromboembolic disorders, and hypersensitivity to VAGIFEM constituents.
|
|
Antifungal
|
Itraconazole injection
Sporanox® IV injection
Janssen
|
The United States FDA approved this antifungal agent in March, 1999, for treatment of histoplasmosis, blastomycosis, and refractory aspergillosis, including use in immunocompromised patients. Contraindications include use with specific other drugs, such as Propulsid (cisapride), Halcion (triazolam), Versed (midazolam), Mevacor (lovastatin) or Zocor (simvastatin).
|
|
Wound care
|
Becaplermin
Regranex® Gel 0.1%
Johnson & Johnson/McNeil
|
The European Commission approved this wound healing agent in April, 1999, for the treatment of full thickness neuropathic, chronic diabetic ulcers.
|
|
Topical Anesthetic
|
Lidocaine/prilocaine
EMLA® cream
Astra
|
The United States FDA approved the additional indication of use in pediatric patients.
|