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BFAD Bureau Circular No. 18 (2005)

BFAD Bureau Circular · October 12, 2005

(NAR) VOL. 16 NO. 4 / OCTOBER - DECEMBER 2005

[ BFAD BUREAU CIRCULAR NO. 18, S. 2005, October 12, 2005 ]

NEW ADVISORY ON LABELING SELECTIVE CYCLOXYGENASE -2 (COX -2) INHIBITORS AND NON- STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)

In pursuance to further enhance safe use of selective Cycloxygenase-2 (COX-2) inhibitors and non-steroidal anti-inflammatory drugs (NSAIDS), the BFAD would like to issue the following directives:

1. Companies are instructed to use remedial labeling to their package inserts of the existing stocks.

2. The remedial labels shall include the boxed warning stating absolute * * contraindications for COX-2 and NSAIDS. Please refer to Annexes A and B of BC No. 11, s. 2005.

3. Companies are granted up to 31 March 2006 to exhaust these stocks with remedial labeling. For immediate compliance of those concerned. Adopted: 12 Oct. 2005

(SGD.) PROF. LETICIA BARBARA B. GUTIERREZ, MS Director IV * Please See NAR 16 Volume 2, page 741.

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