Update on Drugs and Drug News - Number 6 1999

Corticosteroids

Alendronate
Fosamax
Merck

The US FDA approved this drug in June, 1999, for treatment of glucocorticoid-induced osteoporosis in patients receiving glucocorticoids in a daily dosage equivalent to ≥ 7.5 mg prednisone and who have low bone mineral density.

Anticancer Agents

Alitretinoin
Panretin Gel 0.1%
Ligand Pharmaceutical

The US FDA approved this small molecule, nonpeptide hormone in January, 1999, for topical therapy for cutaneous lesions in patients with AIDS-related Kaposi’s Sarcoma. In June, 1999, HPB Ottawa issued a Notice of Compliance for this gel for the same indications.

Antihelminthic Agents

Malathion
Ovide 0.5% Lotion
Medicis Pharmaceutical

The US FDA approved this lotion in May, 1999, for treatment of head lice and their ova.

HIV and AIDS

Abacavir Sulfate
Ziagen
Glaxo Wellcome Inc

HPB Ottawa approved this nucleoside analogue reverse transcriptase inhibitor in June, 1999, for the treatment of HIV and AIDS.

Anticancer Agents

Interferon alpha-2a
Roferon-A
Hoffmann-La Roche

The European Commission (CPMP) approved this drug in June, 1999, for the adjuvant treatment of malignant melanoma patients at risk of relapse following resection.

Topical Anesthetics

Lidocaine Patch 5%
Lidoderm
Endo Pharmaceuticals

The US FDA approved this topical anesthetic in May, 1999, for treatment of pain associated with postherpetic neuralgia. The patch is an adhesive material with 5% lidocaine applied to a nonwoven polyester felt backing. The lidocaine is released into the epidermal and dermal layers of the skin.

Antidiabetic Agents

Pexiganan acetate
Locilex cream 1%
Magainin Pharmaceuticals

The US FDA has deemed this new drug as NOT approvable in July, 1999. It was intended to treat diabetic foot ulcers.

Photodynamic Therapy

Aminolevulinic acid
Levulan Photodynamic Therapy
DUSA Pharmaceuticals

The US FDA issued an approvable letter in June, 1999, for the treatment of multiple actinic keratoses of the face and scalp.

Antifungal Agents

Ketoconazole
Teva

The US FDA approved this generic version of 200 mg ketoconazole tablets in June, 1999. They are AB rated and bioequivalent to Janssen’s Nizoral® tablets.

Antiviral Agents

In May, 1999, The Canadian Dermatology Committee (CDC) recommended that all children entering preschool or elementary school should be immunized against chicken pox. Previously, the CDC and the American Academy of Pediatrics advocated that this immunization should take place between the ages of 12-18 months.

Antirejection Therapy

The US FDA approved a generic formulation of cyclosporine (SangCya—Sangstat) in May, 1999. The generic formulation appears to be bioequivalent and therapeutically equivalent to Neoral, and both have been more consistent in bioavailability than Sandimmune.