|
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.
|