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NOTICE: NOTICES

ACTION: Reports and guidance documents; availability, etc.:

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AZOPT (brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.

SUMMARY: Best Pharmaceuticals for Children Act—; Pediatric studies; AZOPT, BETAXON, and GLEEVEC; medical and clinical pharmacology review summaries,

SUPPLEMENTAL INFORMATION

FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for AZOPT (brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). The summaries are being made available consistent with section 9 of the BPCA (Public Law 107109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain important changes, the pediatric exclusivity program described in section 505A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355a). Section 505A of the act permits certain applications to obtain 6 months of marketing exclusivity if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population.

One of the provisions the BPCA added to the pediatric exclusivity program pertains to the dissemination of pediatric information. Specifically, for all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are to be made available not later than 180 days after the report on the pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent with this provision of the BPCA, FDA has posted on the Internet at http://www.fda.gov/cder/pediatric/index.htm summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AZOPT (brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). Copies are also available by mail (see ADDRESSES). II. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/cder/pediatric/index.htm.

Dated: December 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E622517 Filed 1307; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Grace Carmouze, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6460, Silver Spring, MD 209930002, 301 7960700, email: grace.carmouze@fda.hhs.gov.