Ibuprofen ANDA Status Backed By Dr. Reddy’s; Foreign-Sources Defended
This article was originally published in The Tan Sheet
Executive Summary
Dr. Reddy's Labs claims "there is no need whatsoever" to include ibuprofen 200 mg in the Internal Analgesic, Antipyretic & Anti-rheumatic Drug Products Tentative Final Monograph, in recent comments to FDA
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Dr. Reddy's Labs claims "there is no need whatsoever" to include ibuprofen 200 mg in the Internal Analgesic, Antipyretic & Anti-rheumatic Drug Products Tentative Final Monograph, in recent comments to FDA. "Ibuprofen is a drug with a potential bioequivalence problem," the generic firm points out, praising FDA's current policy of requiring a new drug application or abbreviated new drug application to include various in vitro studies. "The requirements, among others, serve to ensure that generic products can be expected to provide the same therapeutic benefit as their brand name counterparts," the Sept. 5 comments state. Dr. Reddy's appears to be trying to avoid the likely surge of competition that would result in the generic ibuprofen market if FDA finalizes the comparatively less rigorous process for getting to market via a monograph. "The current ANDA approval requirements for marketing ibuprofen has helped ensure that the public has access to the highest quality, therapeutically equivalent, less expensive versions of ibuprofen," the comments maintain. The Hyderabad, India-based firm's comments respond to an August 2002 proposal to include ibuprofen in the IAAA TFM, as well as to "comments alleging that foreign sources of ibuprofen active pharmaceutical ingredients and finished dosage forms contain unsafe levels of lead and/or chromium" (1 (Also see "Ibuprofen Detailed Renal, GI Warnings Required For Monograph Inclusion" - Pink Sheet, 26 Aug, 2002.), p. 3 and 2 (Also see "Ibuprofen Detailed Renal, GI Warnings Required For Monograph Inclusion" - Pink Sheet, 26 Aug, 2002.), p. 5). In separate comments to FDA responding to the agency's proposal, domestic ibuprofen suppliers BASF and Albemarle Corp. suggested foreign sources of bulk ibuprofen may contain potentially toxic levels of lead and chromium. In an effort to "address allegations," the generic sent samples of its ibuprofen lots to an independent good laboratory practices-compliant lab to test for trace amounts of metals. "Twenty-six different lots of ibuprofen API manufactured by [the firm] were tested and no lead, chromium or nickel were detected," comments state. |