Able Labs

Executive Summary

Dingell subcommittee's interest in the generic firm is focused on the company's conjugated estrogens ANDA and the events surrounding FDA's policy change on bioequivalence requirements for generic versions of Wyeth-Ayerst's Premarin, Able says. Attachments to a March 14 letter from Rep. Dingell (D-Mich.) and Rep. Bliley (R-Va.) to HHS Secretary Sullivan on the investigation of FDA's generic division list Able as one of six companies for which Dingell is seeking compliance records and AF jackets from FDA ("The Pink Sheet" March 27, p. 7). Able says it is not involved in the ongoing criminal investigation by a Baltimore grand jury.