ClassName/CompanyApproval Dates and Comments


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


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



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.



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



Dermik Laboratories

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



Vical Inc

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

Drug News


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 treatment’s 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.


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 FDA’s 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.