26 December 2001 16:14 [Source: ICIS news]
HOUSTON (CNI)--Shares of drug maker Schering-Plough (S-P) were off Wednesday following the company's announcement that it may pay a fine as high as $500m (Euro568m) to resolve complaints about its manufacturing practices.
S-P's announcement that the US Food and Drug Administration (FDA) had given the company marketing clearance for its antihistamine Clarinex - billed as the successor to best-selling drug Claritin - failed to move the market.
Shares of S-P were off 21 cent to $36.90 in early trading today on the New York Stock Exchange - down from the company's 52-week high of $58.31 and just above its yearly low of $32.35.
The Kenilworth, New Jersey-based company said late last week it was negotiating with the FDA to resolve complaints about the company’s compliance with current Good Manufacturing Practices (cGMPs) at manufacturing facilities in New Jersey and Puerto Rico.
S-P said the results could include a possible payment to the US that may be as high as $500m "subject to resolution of other terms of the final agreement."
At the same time, S-P announced FDA approval of Clarinex and said it expects to launch the drug in January.
Said Richard Zahn, president of Schering Laboratories, the US prescription pharmaceutical marketing arm of Schering-Plough: "Offering proven clinical benefits in the management of seasonal allergic rhinitis, Clarinex continues Schering-Plough’s heritage of introducing important therapies to the allergy treatment marketplace."
Allergies affect an estimated 45m Americans, the company said.
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