LILLY DISCONTINUING MANUFACTURE OF 60 PRODUCT

Executive Summary

LILLY DISCONTINUING MANUFACTURE OF 60 PRODUCT dosage forms and package sizes, the company told wholesalers in a March 26 letter. In addition to providing a list of the 60 product discontinuations, the letter says that wholesalers should "continue to fill orders from these items from inventory [and] upon exhaustion of inventory, code these items as 'manufacturer discontinued' when orders are processed." Lilly is taking advantage of the regulatory situation regarding its Indianapolis Building 100 ("The Pink Sheet" Nov. 6, p. 3) to purge itself of older drug products or drugs that are not widely used. For example, among the products being discontinued are atropine sulfate 0.4 mg tablets in bottles of 100, bacitracin 500 units/g in 1/2 and 1 oz. tubes, methyltestosterone 25 mg tablets in bottles of 100, papaverine HCl 60 mg tablets in bottles of 100, paregoric in gallon containers, neomycin 500 mg, and several different dosage forms and packaging sizes of potassium chloride and terpin hydrate. The letter notes that 10 of the 60 products and dosage forms it is discontinuing are not available from any other manufacturer, including Darvon (propoxyphene HCl) 32 mg pulvules. However, Lilly and generic firms make propoxyphene HCl 65 mg products. Lilly is also discontinuing its Axid (nizatidine) 150 mg pulvules in convenience paks of 30 and Keflex (cephalexin) 125 mg/5 ml and 1 g products. But Lilly manufactures other dosages and packages of Axid, including 150 mg pulvules in prescription packages of 60, and 300 mg pulvules in convenience paks of 30. Keflex is still available in 250 and 500 mg tablets. A Lilly spokesperson said that the company periodically reviews its products "with a number of issues in mind: medical need, current demand...and any kind of manufacturing issues that might exist, and...periodically decides to discontinue some products." The spokesperson acknowledged that "some of the decisions on some of the products" were a result of the company's review of product lines as part of Lilly's "action plan" to deal with the problems at Building 100. Following suspension of all shipments from Building 100 last August, Lilly, under an agreement with FDA, has been reintroducing drugs on a product-by-product basis. The suspension was in response to an FDA inspection report that detailed numerous good manufacturing practice violations. Lilly's product review is "still ongoing," and "the majority of the products from that facility that are going to be brought back, have been," the spokesperson said. Axid and Darvon are some of the products manufactured in Building 100. Product recalls for Axid (May 1988) and Darvon (June 1988) due to dissolution failures led to FDA's inspection of the facility. In October, Lilly withdrew seven lots of Axid 150 mg pulvules because a manufacturing process did not ensure stability.