|Class||Name/Company||Approval Dates and Comments|
The US FDA’s Dermatologic and Ophthalmic Drug Advisory Committee recommended approval of this selective immunomodulator in May 2002, for the treatment of moderate-tosevere chronic plaque psoriasis
The US FDA granted marketing approval in April 2002. Clinical trial results for this product demonstrated an 88% effectiveness rate in healing refractory leg and foot ulcers.
The US FDA granted marketing approval in April 2002, as a shortterm treatment for moderate-to-severe melasma of the face in the presence of measures for sun avoidance, including the use of sunscreens.
The US FDA’s Nonprescription Drugs Advisory Committee endorsed approval of this drug in April 2002, as an OTC treatment for chronic idiopathic urticaria, or chronic hives of unknown cause. The committee also recommended that the indications might be broadened to include general hives once sufficient data are submitted.
Baxter Bioscience issued a warning letter in May 2002, to health care providers regarding the possible association between immune globulin intravenous (human) (IGIV) administration and thrombotic events. They suggest strict attention to the precautionary statements included in the package insert for Gammagard S/D, that recommend exercising caution in the prescribing of IGIV for patients with a history of cardiovascular disease of thrombotic episodes.
New Drugs and Side-Effects
A study published in a recent issue of the Journal of the American Medical Association estimates that 20% of recently approved prescription drugs have serious side-effects that may only be discovered after a drug has been on the market for years. Researchers suggest that health care providers prescribe older medication whenever possible and that the US FDA set higher standards for approval of new drugs when effective alternatives are available.
Atopic Dermatitis Agents
According to data presented by D. Pariser, et al, at the Society for Investigative Dermatology Congress in Los Angeles, in May 2002, atopic eczema affecting babies, as well as sensitive skin areas such as the face has been successfully treated with the new non-steroid pimecrolimus cream (Elidel®). In patients aged 3 months to 18 years, Elidel® reduced the severity of eczema by an average of 64% over 6 weeks. The prescription medication was first launched in the US in February 2002, for the treatment of mild-tomoderate atopic eczema in patients aged 2 years and older. In March 2002, it gained its first European approval, in Denmark, for the short term treatment of atopic eczema and intermittent long term treatment to prevent progression to flares in patients aged 3 months and above.