ANDA An abbreviated new drug application (ANDA) has been awarded to Mikart, Inc. and Pamlab, L.L.C. for the purpose of manufacturing and marketing carbinoxamine maleate in the form of 4mg, USP tablets and 4mg/5mL oral solution / liquid. These products are marketed under the brand name PALGIC®. This listing appeared on the FDA / CDER website in May, 2003. This listing appeared in the Orange Book (electronic) in May, 2003 The original new drug application (NDA) was granted to McNeil Laboratories, Inc.® under the brand name of Clistin® in 1963. The original NDA was "withdrawn for sale", but not because of safety or efficacy concerns. Further information on this matter may be obtained from the Food and Drug Administration. A copy of the ANDA statement may be viewed here. "Unapproved" Products The FDA Office of Compliance/ Division of Prescription Drug Compliance and Surveillance has issued an advisory letter stating that some manufacturers are currently marketing unapproved versions of carbinoxamine maleate. As of June, 2003 the FDA Office of Compliance has announced "immediate enforcement action to prevent further marketing of unapproved (carbinoxamine maleate) products." This letter was issued at the request of Mikart, Inc and Pamlab, LLC which hold abbreviated new drug application, (ANDA) for two carbinoxamine maleate products: PALGIC® 4mg, USP, tablets and PALGIC® 4mg/5mL, USP, oral solution. A copy of the "Unapproved Product" letter may be viewed here. History / ANDA / Clinical Studies / Monographs / Resources / Home McNeil Laboratories, Inc.® and Clistin® are registered trademarks of McNeil Laboratories, Inc., Fort Washington, PA 19034. PALGIC® is a registered trademark of Pamlab LLC, Covington, LA, 70433