Approval of new
treatments for osteoporosis, attention deficit disorder and impotence shouldn't be affected by manufacturing problems at its Indianapolis plant, the company said.
Lilly also reaffirmed its estimate from Oct. 23, saying fourth-quarter and 2003 earnings would be below analyst expectations, hurt by delays for new product approvals and higher marketing expenses.
Speaking to analysts on a call, the drug giant said there aren't any outstanding manufacturing issues that would prevent U.S. approval for the osteoporosis drug, Forteo, or the attention disorder drug, Strattera. And Lilly's experimental impotence treatment, Cialis, won't be delayed because it's made at another facility.
Still, FDA still must conduct inspections related to the manufacture of new depression medicine Cymbalta and an injectable form of schizophrenia drug Zyprexa.