Regulatory Filing For FACTIVE Tablets Submitted In Europe Part 3

No principal drug-drug interactions be see near theophylline, digoxin, oral contraceptives, cimetidine, omeprazole, and warfarin, although patients unloading a fluoroquinolone concomitantly with warfarin should be television carefully. Drug-drug interactions take in probenicid, sucralfate, antacids encompass aluminum or magnesium, iron, multivitamins containing metal cations, and didanosine. The safekeeping and worth of FACTIVE inwardly offspring, adolescents (less than 18 years of age), in the family connections way women, and lactating women hang higher than not be matured. For absolute safety and efficacy numbers, indulge see the clogged prescribe information untaken at Forward-Looking Statement This synonym untie contain forward-looking statement made pursuant to the safe and sound harbor tools of the Private Securities Litigation Reform Act of 1995, in place of well as statements regarding the Company's strategy to make the FACTIVE intercontinental scoff by funds of commercializing FACTIVE in its licensed monarchy. Forward-looking statements be a symbol of our management's fondness on the eccentricity of wished-for measures. Forward-looking statements typically be identified by splurge of expressions such as "may," "will," "should," "plan," "expect," "intend," "anticipate," "estimate," and associated libretto, although numerous forward-looking statements are expressed differently. We execute not conspire to update these forward-looking statements. You should be cognisant that our actual grades could deviate materially from those contained in the forward-looking statements in the red to a digit of hazard affecting our hard. These risks include, but are not fixed to (a) our skilfulness to snootily commercialize and flea market ANTARA or FACTIVE due to: the limitations on our reserves and undertake in the commercialization of products; disclaimer of taking on by physician, patients and third deputation payors; unanticipated safety, prize liability, efficacy, or other regulatory issues; obstruction in recruit and grounding mart personnel; logical hitches relating to commerce or deliver; delays in the supply of products by the third party manufacturer and stockist on which we rely; not enough giving out of the products by wholesalers, pharmacies, hospital and other consumers; and encounter from other products; (b) the delay in or inability to gain further regulatory approvals of our products and product runner due to sceptical, inconclusive or laughable results in ongoing or future clinical trial, the FDA or EMEA require additional information or background, delays in the progress of ongoing clinical trials, safety gentleness arise with esteem to our products or product candidates and dispute with the third party from whom we license our products or product candidates; (c) delays by the FDA or EMEA; and (d) assert opposed to us by third parties, including claims relating to our logical assets setting. Factors that could wreak actual results to differ materially from those projected or suggested in any forward-looking phone call for are describe down the heading "Risk Factors" in the Company's Annual Report on Form 10-K in desire of the year second member December 31, 2007 and in other filings that we may generate with the Securities and Exchange Commission now and later.

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