said Tuesday that U.S. drug regulators issued an approvable letter for the schizophrenia drug Abilify.
Final approval for Abilify, also known by the medical name aripiprazole, is contingent upon final negotiations with the Food and Drug Administration, the companies said.
Otsuka, a privately held Japanese drugmaker, submitted an approval application for Abilify in October 2001.
Bristol-Myers is hoping to use Abilify's approval as a springboard for recovery from a host of woes over the last year, including well-publicized setbacks with its
partnership, inventory problems that are now the subject of a formal
Securities and Exchange Commission
query, and competition from generic drugs that has cut earnings 50% this year.
In clinical studies, Abilify has proven to cause fewer side effects than other drugs for the treatment of schizophrenia. If approved, Abilify would compete with drugs like Zyprexa from
and Risperdal from
Johnson & Johnson
. Several analysts see Abilify as a billion-dollar seller.
Bristol-Myers shares closed Friday at $24.95.