AMITYVILLE, N.Y., Mar 21, 2011 (BUSINESS WIRE) --
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that it has
acquired the rights to the Abbreviated New Drug Application (ANDA) for
Nystatin Oral suspension from Bausch + Lomb, the global eye health
company for an undisclosed upfront payment and a future royalty.
Nystatin oral suspension is indicated for the treatment of candidiasis
in the oral cavity. The market for Nystatin oral solution was $23
million based on IMS data. Hi-Tech intends to launch Nystatin oral
solution in all commercially available fill sizes as soon as it
satisfies all applicable FDA requirements.
Hi-Tech currently has 14 products awaiting approval at the FDA,
targeting brand and generic sales of approximately $1.0 billion. In
addition, Hi-Tech has 20 products in active development targeting brand
sales of over $3 billion, including sterile ophthalmic products, oral
solutions and suspensions and nasal sprays.
About Hi-Tech Pharmacal
Hi-Tech is a specialty pharmaceutical company developing, manufacturing
and marketing generic and branded 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. Hi-Tech's
ECR Pharmaceuticals subsidiary markets branded prescription products.
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.
SOURCE: Hi-Tech Pharmacal Co., Inc.
Hi-Tech Pharmacal Co., Inc.
Bill Peters, 631-789-8228