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Update on Drugs and Drug News - Number 2 1999


Class Name/Company Approval Dates and Comments

Photodynamic Therapy

Aminolevulinic Acid
Levulan Photodynamic Therapy
DUSA Pharmaceuticals

The US FDA approved Levulan PDT in December 1999, for the treatment of actinic keratoses. Schering AG - Berlin and DUSA Pharmaceuticals have entered into an agreement giving Schering AG exclusive marketing and distribution rights in the US, Europe and the rest of the world, except Canada. They are planning to launch this product in the second quarter of 2000.

Anticancer Agents

G-3139
Genta Inc

The US FDA granted fast-track designation in October 1999, to this bcl-2 antisense compound for use in combination with dacarbazine. It is indicated for treatment of advanced malignant melanoma.

Antibacterial Agents

Moxifloxacin HCl
Avelox
Bayer

An advisory committee to the US FDA recommended approval in October 1999, of this quinolone antibiotic for the treatment of uncomplicated skin and skin structure infections, acute sinusitis, acute bacterial exacerbations of chronic bronchitis, and community-acquired pneumonia.

Antifungal Agents

Ciclopirox
Loprox 8% Topical Solution
Hoechst-Marion Roussel

The US FDA approved this nail lacquer in December 1999, for the treatment of mild to moderate onychomycosis.

Keratolytic Agents

5-fluorouracil
Solex
Dermik Laboratories

An NDA was submitted in October 1999, for a treatment using 5-fluorouracil in Advanced Polymer Systemís Microsponge system. This treatment has demonstrated efficacy in reducing actinic keratoses.

Anticancer Agents

Allovectin-7
Vical Inc

The US FDA granted orphan drug designation to this drug in October 1999, for the treatment of invasive and metastatic melanoma.


Drug News

Anorectal Preparations

Pivotal Phase III trial results for nitroglycerin ointment (Anogesic) were released in November 1999. They fell short of efficacy requirements for treatment of chronic anal fissures. Cellegy Pharmaceuticals plans to analyze the trial data and meet with the US FDA to determine the treatmentís future course.

OTC Products

The US FDA issued a final rule in September 1999, that all OTC drug products containing colloidal silver or silver salts have been misbranded and are not recognized as safe and effective, and manufacturers will no longer be able to market them. These products were labelled to treat adults and children for HIV, AIDS, cancer, tuberculosis, malaria, lupus, syphilis, scarlet fever, shingles, herpes, pneumonia, typhoid and tetanus.

HIV and AIDS

Researchers at the National Institute of Allergy and Infectious Diseases hypothesize that HIV may continue to infect CD4+ T-cells after treatment with current HIV drugs. They suggest that current HIV drugs may never eliminate the virus from the body, though treatment can keep the virus levels stable.

Hair Growth

The US FDAís pharmacy compounding committee in November 1999, recommended against including dinitrochlorobenzene (DNCB) and diphenylcyclopropenone (DPCP) on a list of drug substances that can be used in compounding. These substances were used to treat alopecia areata and resistant viral warts.


In this issue:

  1. Topical Antipsoriatics
  2. Treatment Options For Localized Scleroderma
  3. Update on Drugs and Drug News - Number 2 1999