Tokyo, Japan, September 25, 2009 - Astellas Pharma Inc. (headquarters: Tokyo; President and CEO: Masafumi Nogimori; “Astellas”) today announced that Boehringer Ingelheim Pharmaceuticals, Inc. (“BIPI”) received notice from the US Food and Drug Administration (FDA) that the pediatric data provided by BIPI for FLOMAX® (generic name: tamsulosin hydrochloride, brand name in Japan: Harnal®) in pediatric patients with neurogenic bladder satisfactorily met the terms of a January, 2006 Written Request. Based upon this determination, an additional 6-month of pediatric exclusivity for FLOMAX has been granted. The additional period attaches to the US patent covering FLOMAX, such that the associated exclusivity now extends to April 2010.
Tamsulosin hydrochloride was invented and developed by Astellas for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) and has been marketed in approximately 90 countries/areas since it was launched in Japan in 1993. In the US, under a license from Astellas, BIPI has been marketing the product since 1997 under the brand name FLOMAX. Since October 2004, Astellas Pharma US, Inc., a US subsidiary of Astellas, has been co-promoting the product with BIPI.
Important Safety Information about FLOMAX
FLOMAX is approved to treat male urinary symptoms due to BPH, also called an enlarged prostate. FLOMAX is not approved for use in pediatric patients. Only your doctor can tell if you have BPH, not a more serious condition like prostate cancer. Avoid driving or hazardous tasks for 12 hours after your first dose or increase in dose, as a sudden drop in blood pressure may occur, rarely resulting in fainting. If considering cataract surgery, tell your eye surgeon you’ve taken FLOMAX. Common side effects are runny nose, dizziness and decrease in semen.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Before taking FLOMAX capsules, please see the full Prescribing Information and Patient Information, available at www.4FLOMAX.com.