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Update on Drugs and Drug News - Number 5 1998

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.


Trovafloxacin (oral) Alatrovafloxacin (IV)

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.


Zidovudine 300 mg/ lamivudine 150 mg
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.
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

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 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.



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.

In this issue:

  1. Current Review of the Alpha-hydroxy Acids
  2. FDA Warning about Isotretinoin ( Accutane®, Roaccutane®)
  3. Update on Drugs and Drug News - Number 5 1998