16.01.2008 15:50:00
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Hi-Tech Pharmacal Receives Final Approval for Fluticasone Propionate Nasal Spray, 50mcg
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®, 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.”
Hi-Tech is a specialty pharmaceutical company developing, manufacturing
and marketing branded and generic prescription and OTC products for the
general healthcare industry. The Company specializes in difficult to
manufacture liquid and semi-solid dosage forms and produces a range of
sterile ophthalmic, otic and inhalation products. The Company's Health
Care Products Division is a leading developer and marketer of branded
prescription and OTC products for the diabetes marketplace.
Forward-looking statements (statements which are not historical facts)
in this press release are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements are not promises or guarantees and investors are cautioned
that all forward-looking statements involve risks and uncertainties,
including but not limited to the impact of competitive products and
pricing, product demand and market acceptance, new product development,
the regulatory environment, including without limitation, reliance on
key strategic alliances, availability of raw materials, fluctuations in
operating results and other results and other risks detailed from time
to time in the Company's filings with the Securities and Exchange
Commission. These statements are based on management's current
expectations and are naturally subject to uncertainty and changes in
circumstances. We caution you not to place undue reliance upon any such
forward looking statements which speak only as of the date made. Hi-Tech
is under no obligation to, and expressly disclaims any such obligation
to, update or alter its forward-looking statements, whether as a result
of new information, future events or otherwise.
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