FDA internal analgesics

Comment period on agency's proposal to amend internal analgesics tentative final monograph to include ibuprofen reopened until Sept. 2, FDA says in 1June 4 Federal Register notice. In October, Wyeth requested additional time to evaluate labeling suggestions made during NDAC meeting on internal analgesic products (2"The Tan Sheet" Oct. 28, 2002, In Brief). Firm also said it might conduct consumer research on information relevant to crafting appropriate label. FDA "acknowledges that additional time may be beneficial to fully evaluate and respond to the issues." Agency proposed the amendment in August (3"The Tan Sheet" Aug. 26, 2002, p. 3)...

Comment period on agency's proposal to amend internal analgesics tentative final monograph to include ibuprofen reopened until Sept. 2, FDA says in ¹ June 4 Federal Register notice. In October, Wyeth requested additional time to evaluate labeling suggestions made during NDAC meeting on internal analgesic products (² 'The Tan Sheet' Oct. 28, 2002, In Brief). Firm also said it might conduct consumer research on information relevant to crafting appropriate label. FDA "acknowledges that additional time may be beneficial to fully evaluate and respond to the issues." Agency proposed the amendment in August (³ (Also see "Ibuprofen Detailed Renal, GI Warnings Required For Monograph Inclusion" - Pink Sheet, 26 Aug, 2002.), p. 3)....