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Hi-Tech gets FDA OK for generic Flonase

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January 16, 2008

AMITYVILLE, N.Y.—Hi-Tech Pharmacal Co. Inc. said Wednesday the Food and Drug Administration granted final approval to the drug maker's generic version of GlaxoSmithKline PLC's nasal spray Flonase for the management of nasal allergy symptoms.

Shares of Hi-Tech jumped $1.75, or 18.4 percent, to $11.27 in afternoon trading.

The FDA approved Hi-Tech's abbreviated new drug application for fluticasone propionate nasal spray, Flonase, at 50 micrograms.

Hi-Tech said it will begin shipment immediately.

Flonase generated 49 million pounds, or about $100 million, in total third-quarter sales.

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