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UPDATE 1-FDA rejects Schering-Merck combo allergy drug
April 26, 2008 / 2:40 AM / 9 years ago

UPDATE 1-FDA rejects Schering-Merck combo allergy drug

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NEW YORK, April 25 (Reuters) - 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 reasons.

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) (Reuters messaging: 646 223 6000)

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