Hi-Tech Pharmacal Receives Final Approval for Fluticasone Propionate Nasal Spray, 50mcg

AMITYVILLE, N.Y.--(BUSINESS WIRE)--Jan 16, 2008 - Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for fluticasone propionate nasal spray, 50mcg. Hi-Tech's fluticasone propionate nasal spray is the AB-rated generic equivalent of GlaxoSmithKline's Flonase(R), which is used in the management of the nasal symptoms of seasonal and perennial allergic and non-allergic rhinitis. Sales of branded and generic fluticasone propionate nasal spray, 50mcg was over $700 million for the 12 months ended June 2007 according to IMS sales data. Hi-Tech will begin immediate shipment of fluticasone propionate nasal spray, 50mcg.

David Seltzer, President and CEO of Hi-Tech Pharmacal said, "We are very excited about the approval of fluticasone propionate nasal spray. Given the large size of the market and the limited number of competitors, we are optimistic about the contribution that this product will make to the Company's sales and profits."