received contingent regulatory approval Monday for its new depression drug Cymbalta, but final go-ahead to market the product won't be granted until the drugmaker clears up previously disclosed manufacturing problems.
The Food and Drug Administration has identified problems at eight of Lilly's manufacturing plants, which has forced the drugmaker to
warn of possible delays in several of its new products. A Lilly spokeswoman said the company expects to get more details from the FDA in the next two months, at which point it will have a better idea of just how long it will take to fix the problems.
In July, Lilly said it hoped to have the manufacturing issues cleared up in early 2003, but it took back financial guidance for the year until it had a better handle on the situation.
Monday, the FDA issued an "approvable letter" for Cymbalta, Lilly said, but the drug won't be granted final approval because the drug is made at one of the plants identified as substandard by the agency.
Cymbalta works by elevating the levels of two neurotransmitters in the brain -- serotonin and norepinephrine. Most drugs to treat depression regulate just a single neurotransmitter.
Shares of Lilly were up 31 cents, to $58.38 in recent trading Monday.