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The Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA) issued a positive opinion recommending approval of these formulations in January 2002 for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The syrup is recommended for patients >2 years of age, and the disintegrating tablets are labeled for patients >12 years of age.
The US FDA approved an IV formulation of this antibacterial agent in December 2001, for the treatment of community-acquired pneumonia, uncomplicated skin and skin structure infections, acute bacterial sinusitis, and acute bacterial exacerbations of chronic bronchitis in adults. Avelox is also available in tablet form. The IV and tablet forms are bioequivalent, so no dosing adjustment is required.
New Zealand’s regulatory authority gave marketing authorization in February 2002, for the treatment of actinic keratosis and basal-call carcinoma in patients for whom traditional therapies are unsuitable. This treatment is already approved in 14 European countries and applications are pending in Australia, the US and Switzerland.
The US FDA approved this product in January 2002, for the treatment of psoriatic arthritis.
The US FDA approved this cream in January 2002, for the shortterm treatment of moderate to severe melasma of the face in the presence of sun-avoidance measures, including sunscreen use.
According to an article published in the British Journal of Clinical Pharmacology* St. John’s Wort, which is a popular herbal treatment for depression, increases P-glycoprotein expression. As a result, patients taking drugs that act as P-glycoprotein substrates, such as indinavir and cyclosporin, should not take this herbal remedy. *British Journal of Clinical Pharmacology 53:75-82 (2002)
New Topical Delivery System
CollaGenex Pharmaceuticals has licensed a novel dermal and transdermal drug delivery system named Restoraderm®. This technology is designed to enhance the dermal delivery of a variety of active ingredients, and is based on the ability of certain lipid compositions to enhance the natural skin barrier to facilitate dermal and transdermal delivery. This technology is currently still under development.
Bristol-Myers Squibb Canada announced that Videx ED® (didanosine) is now available for sale in Canada as of January 2, 2002. This nucleoside analogue is used to treat adults who are infected with HIV, with a dosage of 1 capsule daily.