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Many drug names fail to pass FDA muster

...In the 2004 fiscal year, the agency's name-safety reviewers turned down 123, or 36 percent, of the proposed names they received.

That was up from 90, or 29 percent, the year before, and 86, or 31 percent, in 2002.

The rejection rate now may be even higher.

The FDA recently toughened its procedure by requiring that possible names be checked against overseas brands because of concerns about U.S.

drugs that have names identical to some used abroad, but very different uses.To find out whether a drug works, a manufacturer runs studies, with the guidance of the FDA.

The agency then decides whether the product merits approval.

With a proposed name, the agency does its own internal tests to see whether the name is likely to be confused with that of an existing drug.

The tests involve writing the names on mock prescriptions to check how they would look in real-world conditions, conducting Web searches and using a proprietary software program that the agency has never released.The pharmaceutical companies, adept at getting their way on big Washington policy matters, admit to being stumped sometimes by the process.

The proof: a graveyard of expensive but never-used drug names.Eli Lilly & Co.

reaped a bonanza of positive brand publicity from a successful clinical trial of its experimental sepsis drug, dubbed Zovant.

But the FDA rejected the name, saying that it was too close to others used in critical care.

The other drugs were Zofran, an antinausea drug, and Zosyn, an antibioti...

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