Class Name/Company Approval Dates and Comments

Actinic
keratoses


Diclofenac sodium


Solarase Gel 3%

Hyal Pharmaceutical

Approved in Canada, May 1998 for the topical treatment of
actinic keratoses.

Antibiotic


Trovafloxacin (oral)
Alatrovafloxacin (IV)


Trovan

Pfizer

Recently approved by the FDA for 14 indications including
skin and skin structure infections. This “fourth generation”
quinolone is given once daily, orally or IV, and is active against
penicillin-resistant pneumococci, gram-negative bacteria,
atypical organisms and anaerobic bacteria.

Anti-HIV


Zidovudine 300 mg/
lamivudine 150 mg


Combivir

Glaxo Wellcome

Approved by the EC Commision. Combivir aims to
improve compliance by reducing the pill burden for HIV
patients on combination antiretroviral therapy.

UV-induced
skin
discolorations


Hydroquinone 4%,
glycolic acid & an
antioxidant complex.


Lustra

Medicis Pharmaceutical

Recently approved by the FDA for the treatment of photoinduced
skin discolorations as well as hyperpigmentation
associated with pregnancy, superficial trauma and the use
of oral contraceptives and hormone replacement therapy.

Antiviral Agent


10% Docosanol Cream

Avanir Pharmaceuticals

The US FDA issued an approvable letter in June 2000, for the treatment of oral facial herpes. Docosanol is the first approvable OTC treatment for this disease.

Oncologic Agent


Bleomycin


ANDA

Gensia Sicor Pharmaceuticals

The US FDA tentatively approved Gensia Sicor Pharmaceuticals’ ANDA in June 2000, for the generic injection form of Bristol-Myers Squibb’s bleomycin (Blenoxane). If fully approved, bleomycin will be used alone or in combination with other chemotherapeutic agents for the management of squamous cell carcinoma, lymphomas and testicular carcinoma.


New Developments

Leprosy


Leprosy vaccine

Approved in India, this vaccine is said to be the first to
stimulate the immune system to kill Mycobacterium leprae.
It is administered intradermally, and given as an adjunct
with standard multidrug therapy is expected to accelerate
healing and reduce the duration and cost of therapy.

Scleroderma


Minocycline


Minocin

Lederle

A preliminary report from workers in Boston suggests that
minocycline may be of benefit in the management of
scleroderma.


New Side Effect

Protease
inhibitors

Lumps, humps and bumps of mature pockets of adipose tissue have been described in patients
taking anti-HIV protease inhibitors, as soon as two months after starting therapy. These
buildups of fatty tissue, which have been termed protease paunches, buffalo humps, horsecollar
buildups and Crix belly, have been seen in patients taking all types of protease inhibitors.