SANDOZ CONTESTING FIORINAL/CODEINE AND CAFERGOT P-B SEIZURES

SANDOZ CONTESTING FIORINAL/CODEINE AND CAFERGOT P-B SEIZURES: the firm says it will continue shipments of Fiorinal with Codeine caps #1, as well as certain lots of #3 caps. FDA filed a seizure action against the Fiorinal with Codeine #3 capsules in Ohio Southern District federal court June 27, charging that the butalbital/aspirin/codeine combination product is a new drug being marketed without an approved NDA. Sandoz said the agency seized approximately 72 bottles and 14 boxes of the #3 capsules on July 3 at the warehouses of Kauffman-Lattimer Co. in Columbus, Ohio. Sandoz declared in a July 3 statement that "in a seizure action such as the one involving Fiorinal with Codeine capsules #3, only those specific bottles and packages that are the subject of the action will be prohibited from being shipped." The firm added: "Other lots of Fiorinal with Codeine capsules #3, as well as other strengths of Fiorinal with Codeine capsules, are at this time unaffected by the pending proceeding. Sandoz will, of course, abide by any final decision of the courts on the issues raised in the seizure action, but pending such decision, Sandoz believes that Fiorinal with Codeine capsules #3 may continue to be shipped and sold legally in interstate commerce." The firm said it will contest the seizure in court. Sandoz also asserted that "without waiving its argument that the product is not a new drug," it has filed an NDA for Fiorinal with Codeine. Sandoz maintained that the capsules have been marketed for over 23 years, "are generally recognized as safe and effective and, therefore, are not new drugs requiring an NDA." FDA initially issued Sandoz a reg letter in November 1984, requesting that the capsules be withdrawn from the market, as part of a DESI class action against unapproved butalbital-analgesic combos. FDA took similar action against another Sandoz DESI product, Cafergot P-B (pentobarbital and belladonna) suppositories, filing a seizure action on May 29 in the federal district court of Massachusetts. Sandoz said it has filed an NDA for Cafergot P-B and that it will also contest the pending seizure. The firm stated that the suppositories are "grandfathered drugs, meeting all the requirements necessary to exempt them from having to obtain an NDA in order to be legally marketed," Sandoz said that only the specific boxes of Cafergot P-B subject to seizure will be discontinued.