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TIME: Almanac 1993
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TIME Almanac 1993.iso
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091189
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09118900.022
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1992-09-23
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BUSINESS, Page 59Business NotesPHARMACEUTICALSThe Capsules That Flunked
At first the growing generic drug-industry scandal was
limited to a few unscrupulous newcomers. But last week the
Government's probe of substandard generics struck an industry
leader, Bolar Pharmaceutical of Copiague, N.Y. The Food and Drug
Administration said that it intends to withdraw its approval of
Bolar's generic version of Dyazide, the top-selling brand-name
hypertension drug. Reason: the FDA says it can no longer be sure
that the generic is biologically equivalent to its brand-name
counterpart. After reviewing Bolar's records, the FDA found that
the company had submitted two batches of its drug for approval
in 1987. Only one passed the equivalency test, but it is unclear
which version reached the market. Bolar claims that only the
effective generic is in drugstores.