NEW YORK, April 25 Drugmakers Schering-Plough
Corp SGP.N and Merck & Co (MRK.N) said on Friday the U.S.
Food and Drug Administration rejected a proposed asthma-allergy
drug that would have combined two best-selling drugs, Claritin
and Singulair, into one tablet.
The two companies said they received a "not-approvable"
letter from the FDA for the combination product. They did not
say whether the drug was rejected for safety, efficacy or other
The drug was the product of a joint venture formed in 200O
to combine the two drugs into a single tablet, a move that
would extend the marketing life of the two drugs as they lose
patent protection. Analysts were not expecting the combo drug
to be a huge seller, however.
Schering's allergy drug, Claritin, one of the best-selling
drugs ever, is now sold generically, while Merck's Singulair is
still covered by patents.
Schering spokeswoman Lisa Ellen declined to elaborate on
why the FDA rejected the product or say if the two companies
planned to resubmit the drug for approval at a later date.
"We're still looking at it, and still evaluating the future
of the joint venture as well," Ellen said.
(Reporting by Dane Hamilton and Ransdell Pierson; Editing by
Carol Bishopric and Alan Raybould)
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