Lilly Cymbalta Halted By GMP Issues; “Approvable” Letter Issued Sept. 13
Executive Summary
Lilly plans to keep the fill-finish production of Cymbalta (duloxetine) in Indianapolis and resolve FDA's good manufacturing practices concerns rather than pursue an alternate manufacturing arrangement for the antidepressant, Lilly said after receiving an "approvable" letter Sept. 13
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Lilly plans to keep the fill-finish production of Cymbalta (duloxetine) in Indianapolis and resolve FDA's good manufacturing practices concerns rather than pursue an alternate manufacturing arrangement for the antidepressant, Lilly said after receiving an "approvable" letter Sept. 13. Cymbalta is the latest Lilly product held up by FDA's GMP concerns with the Indianapolis facility. In at least one other case - the Icos erectile dysfunction drug Cialis (tadalafil) - Lilly is seeking to expedite final approval by shifting production to another plant (1 3 (Also see "Lilly Cialis Using Alternate Manufacturing Facilities For 2nd Half 2003 Launch" - Pink Sheet, 22 Jul, 2002.), p. 10). However, because Cymbalta is manufactured using sustained-release technology that requires specialized techniques, shifting production is not an option, the company said. The "approvable" letter indicates that "approval is contingent upon labeling discussions and resolution of the company's outstanding manufacturing issues," Lilly said. Bulk duloxetine is manufactured in the company's Lafayette, Ind. facility, which was the subject of a 16-item FDA-483 manufacturing report following a pre-approval inspection (2 (Also see "Lilly Dual-Acting Cymbalta Promoted By Dual Sales Force With Quintiles Deal" - Pink Sheet, 29 Jul, 2002.), p. 30). FDA's comments gave Lilly no reason to expect problems with Cymbalta at that facility, the company said. The issues at the Indianapolis plant, on the other hand, may mean a long delay. The company has stated that FDA may not approve any new products (including Zyprexa IM and Forteo ) until the GMP issues are resolved (1 3 (Also see "Lilly Cialis Using Alternate Manufacturing Facilities For 2nd Half 2003 Launch" - Pink Sheet, 22 Jul, 2002.), p. 10). Lilly expects to receive more information from FDA about a timeline for resolving the manufacturing issues in the next two months. The most optimistic timeline would appear to allow the company to launch Cymbalta in April. The drug will mark Lilly's return to the prescription anti-depressant field it helped create with Prozac (fluoxetine). The company remains a leading participant in the larger psychiatric market with the schizophrenia agent Zyprexa (olanzapine). |