|Class||Name/Company||Approval Dates and Comments|
TPP – Canada approved two additional indications for this antipsoriatic agent, one in May 2002, and the second in June 2002. It is now also indicated for the topical treatment of acne vulgaris, and photodamaged skin.
The US FDA approved updated labeling for this anti-acne agent in May 2002. This labeling warns of the risk of musculoskeletal adverse effects. The new warning states that the link to Accuntane® has not been established, but that care should be taken and the drug should be used no longer than the recommended duration of therapy.
The US FDA approved this antihistamine in June 2002, for the treatment of allergy symptoms caused by perennial indoor and seasonal outdoor allergens and chornic idiopathic urticaria in adults and children 12 years of age and older. This product is a rapidly disintegrating formulation and its launch is planned pending US FDA approval of a quality control test revision.
The US FDA approved a new indication and dosage in May 2002, for the treatment of genital and perianal wards and condylomata acuminata. The new dosage approved: apply a thin layer to warts at h.s. 3 times weekly for a maximum of 16 weeks.
Soriatane® (acitretin, Hoffman-La Roche) won two Gold Triangle awards from the American Academy of Dermatology. The first award was in the Industry Communications Campaign category for its Psoria-Sense Patient Education Program, which is a web, e-mail and direct mail-based education program for psoriasis patients. The second award was in the Print Advertising category for a professional sales brochure and ad campaign about the importance and effectiveness of maintenance therapy for psoriasis using this product. The Gold Triangle awards honor excellence in furthering the understanding of dermatologic issues.
Malpractice Concerns in US
In July 2002, the President of the AADA, Fred F. Castrow II, made a presentation before the US House of Representatives, expressing the views of the AADA membership regarding health care litigation reform. He stated that they are very concerned about the current medical malpractice insurance marketplace. Because many of the major insurance companies have stopped carrying this type of insurance, liability premiums are rising, and physicians across the US have reported that they are unable to obtain medical liability insurance. In 2001, eight states saw two or more liability insurers raise their rates by at least 30%. In some areas, only one insurer remains, forcing physicians to face an all or nothing proposition. Dr. Castrow urged the House subcommittee to act favorably on H.R. 4600, the “Help Efficient, Accessible, Low Cost, Timely Health Care ‘HEALTH’ Act of 2002”. This legislation contains much needed medical liability reforms, while continuing to ensure that patients who have been injured through negligence are fairly compensated. Members of the AADA believe that H.R. 4600 will ensure the stability and viability of the health care system in the US.