The U.S. Federal Drug Administration says it can’t approve a new anti-depressant from Labopharm Inc. at this time because an inspection by the U.S. regulator has found deficiencies at an ingredient supplier’s factory.
Shares of the Montreal-area drug maker dropped more than 10 per cent in heavy trading yesterday after the announcement.
Labopharm chief executive James Howard-Tripp says his company intends to work closely with the FDA and the Italian ingredient supplier, the Angelini Group.
Angelini has told Labopharm it will file an action plan with the FDA by Friday.
In the meantime, Labopharm says it will continue to work towards commercializing its new formulation of the antidepressant trazodone.
Labopharm shareholders may be depressed by the news, however. The stock was down 33 cents or nearly 14 per cent at $2.05 on the Toronto Stock Exchange.