ClassName/CompanyApproval Dates and Comments

Photodynamic Therapy

Aminolevulinic Acid

Levulan® Kerastick™
photodynamic therapy

Draxis Health/DUSA

TPP – Canada issued marketing approval to Draxis Health in June
2001, for this product to treat AKs of the face and scalp. Draxis holds
the rights to Levulan® in Canada from DUSA Pharmaceuticals.




Schering Canada

TPP – Canada approved this monoclonal antibody for marketing in
June 2001, for the treatment of severe, active and fistulizing Crohn’s
Disease in adult patients who have not responded to conventional


Butenafine HCl


Bertek Pharmaceuticals

The US FDA approved a new indication in June 2001, for this antifungal
agent. It is now indicated for the treatment of the fungal infection
tinea (pityriasis) versicolor caused by the yeast Pityrosporum



Taro Pharmaceuticals

The US FDA approved this antifungal/corticosteroid cream in May
2001, in the treatment of a variety of dermatological conditions. It is
bioequivalent to Schering-Plough’s Lotrisone® cream.

Drug News

Drug Warning

The US FDA issued a warning to consumers in June 2001, to discontinue use of 13 Chinese herbal products
containing aristolochic acid because they may present serious health hazards. The products are sold under
the Treasure of the East label with the MFG No. 200008 and the manufacturer, Blue Light, Inc., has initiated
a recall.

Drug Warning

The US FDA issued a drug warning in June 2001, stating that myelosuppression, including anemia, pancyptopenia
and thrombocytopenia, has been reported in patients using Linezolid (Zyvox®). Complete blood
counts should be monitored weekly in patients who receive this drug, particularly if they:

  • receive it for longer than two weeks
  • have pre-existing myelosuppression
  • receive concomitant drugs that produce bone marrow suppression
  • have chronic infections who have received previous or concomitant antibiotic therapy.

Antiacne Agent

The US FDA granted six additional months of marketing exclusivity to Accutane® (Isotretinoin, Hoffmann
La Roche) in June 2001, through its pediatric exclusivity program. This means that exclusivity for Accutane®
in the US is in effect until February 7, 2002.

Drug Interaction

In an article published in Clinical Pharmacology and Therapeutics*, Morii, et al, reported that when
mycophenolate mofetil (CellCept®, Roche US Pharmaceuticals) and iron ion preparations were administered
concomitantly, a remarkable reduction in mycophenolate mofetil absorption was observed. The authors
hypothesize that this could be due to formation of a drug-iron complex in the GI tract. They recommend
avoidance of simultaneous administration of these products.

*Clin Pharmacol Ther 68(6):613-6 (2000).

Oncologic Agent Re: Maxamine

The University of Pittsburgh Cancer Institute has reported that the immunomodulating agent Maxamine (histamine dihydrochloride), used in combination with interleukin-2 (IL-2), improved survival for stage IV malignant melanoma patients when compared to those treated with IL-2 alone. Preliminary results also indicated that treatment with Maxamine and IL-2 was safe and well tolerated and had substantially less toxicity than the high-dose regimens of IL-2.

Urticaria Re: Allegra

In June 2000 Aventis Pharmaceuticals announced that Allegra (fexofenadine HCl) 30mg tablets are now available by prescription for the relief of seasonal allergic rhinitis and chronic idiopathic urticaria in children aged 6-11 years. The US FDA approved Allegra for this additional indication in February 2000.