International Approvals: Adderall XR, Gynazole-1, Leuplin SR

Yael Waknine

August 29, 2005

Aug. 29, 2005 — Health Canada has reinstated marketing authorization for a once-daily, extended-release formulation of a single-entity amphetamine product used to treat attention deficit/hyperactivity disorder; butoconazole nitrate 2% vaginal cream has been approved in 21 eastern European countries/territories and Singapore for the treatment of vulvovaginal candidiasis; Japan's Ministry of Health, Labor, and Welfare has approved leuproreline (leuprolide) acetate 11.25-mg depot injection for adjuvant treatment of premenopausal breast cancer to prevent its recurrence.

Amphetamine Product (Adderall XR) Reinstated in Canadian Market

On Aug. 26, Health Canada reinstated marketing authorization for a once-daily, extended-release formulation of a single-entity amphetamine product (Adderall XR, made by Shire Biochem Inc.) used in the treatment of attention deficit/hyperactivity disorder (ADHD). Product availability is expected within two to three weeks.

The drug was withdrawn from the Canadian market on Feb. 9, 2005, due to 20 U.S. postmarketing reports of sudden cardiac death (12 in children) and stroke (two in children) in patients receiving therapy. Although some of the pediatric cases were associated with underlying cardiac abnormalities, others involved unusual and unexplained drug accumulation and toxicity in children who received normal therapeutic doses.

The reversal of the Canadian regulatory agency's decision was based on a review of data by a panel of experts, which concluded that there was insufficient evidence of increased risk associated with the drug compared with other available therapies to support the withdrawal.

A similar review by the U.S. Food and Drug Administration in 2004 found that the rate of sudden deaths and strokes associated with product use did not exceed the background rate for these events in the general population.

Conditions of the Canadian reinstatement include revisions to the product monograph and patient leaflet, and distribution of a letter to healthcare professionals to advise against use of the product in patients with structural heart abnormalities, and to disseminate information regarding the dangers of amphetamine misuse.

In addition, postmarketing surveillance will be enhanced for all stimulant drugs used for the management of ADHD, and safety reports will be submitted to the Canadian agency on a regular basis.

The extended-release amphetamine formulation is approved by Health Canada for use in adults and in children aged six to 12 years, and by the U.S. Food and Drug Administration for use in patients aged six years and older. An immediate-release formulation is approved by the FDA (but not Health Canada) for the treatment of ADHD and narcolepsy.

Butoconazole Nitrate 2% Vaginal Cream (Gynazole-1) Approved in 15 Eastern European Countries and Singapore

Completion in August of the mutual recognition procedure for butoconazole nitrate 2% vaginal cream (Gynazole-1, made by Gedeon Richter, Ltd., under license from KV Pharmaceutical Co.) has allowed use of the product in 15 of 21 eastern European countries/territories.

The drug was also approved in August by Singapore's Ministry of Health (marketed by Pan Malayan), allowing the country to act as a reference member state for further approvals in Asia.

Butoconazole nitrate 2% vaginal cream is indicated for the local treatment of vulvovaginal candidiasis. It was previously approved for use in the U.S., Canada, Mexico, Brazil, Spain, Portugal, and Andorra.

Leuproreline Acetate 11.25 mg (Leuplin SR) Approved for Adjuvant Treatment of Premenopausal Breast Cancer in Japan

On Aug. 18, Japan's Ministry of Health, Labor, and Welfare approved leuproreline (leuprolide) acetate 11.25-mg depot injection (Leuplin SR kit) for the adjuvant treatment of premenopausal breast cancer to prevent its recurrence. The new adjuvant indication also applies to the 3.75-mg injection and kit.

According to a company news release, breast cancer has had the highest prevalence rate of all female cancers in Japan since 1995 and the number of diagnoses is expected to further increase. More than 10,000 people died of breast cancer in 2004 in Japan, accounting for 8.4% of the nation's total fatalities due to malignant neoplasms.

Approval of the 11.25-mg injection is expected to improve the quality of life for women with breast cancer by alleviating the psychological burden of frequent drug administration. The 11.25-mg formulation is administered every 12 weeks compared with the once-monthly 3.75-mg dose regimen.

Leuproreline acetate was previously approved in Japan for the treatment of prostate cancer and endometriosis. It is approved by the U.S. Food and Drug Administration (leuprolide acetate [Lupron], made by Tap Pharmaceutical Products, Inc.) for use alone and with norethindrone acetate 5 mg/day in the management of endometriosis; for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata; and for the palliative treatment of advanced prostate cancer.

Reviewed by Gary D. Vogin, MD

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