In Brief: Pseudoephedrine hydrochloride
This article was originally published in The Tan Sheet
Executive Summary
Pseudoephedrine hydrochloride: FDA may now approve ANDAs for pseudoephedrine hydrochloride 120 mg extended-release capsules, the agency says in a notice published in the Oct. 29 Federal Register. FDA determined that the product, originally marketed by Burroughs Wellcome as Sudafed 12-Hour Capsules, was not withdrawn from the market for safety or effectiveness reasons, and therefore may be marketed by other companies after obtaining an approved ANDA. Burroughs Wellcome ceased marketing Sudafed 12-Hour Capsules and asked that FDA withdraw approval of the new drug application, which it did in September 1995. Drug manufacturer Eurand America requested permission to file an ANDA for the product in a June 1997 citizen petition. Eurand has developed a "taste-masked" pseudoephedrine that it markets to major drug companies ("The Tan Sheet" Feb. 5, 1996, In Brief). FDA will maintain the drug in the "Discontinued Drug Product List" section of the "Orange Book," the notice says...