This article was originally published in The Tan Sheet
CEO Bruce Downey believes Barr has "met the standard the FDA laid out for us in the letter denying our [Plan B switch] application a few months ago," the exec said Feb. 2, explaining the firm's expectation of receiving an "approvable letter" from the agency. "We followed the recommendation, we followed the pathway that was sort of suggested in that letter, I think we have done it...professionally, done it appropriately and we have met all reasonable objections." FDA failed to act on the application by the PDUFA deadline of Jan. 21 (1"The Tan Sheet" Jan. 24, 2005, p. 6)...
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