AMITYVILLE, N.Y.--(BUSINESS WIRE)--Jan. 31, 2012--
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK), a specialty pharmaceuticals
company, announced today that the US Food and Drug Administration, (FDA)
granted final approval for the Company's Abbreviated New Drug
Application, (ANDA) for Lorazepam oral concentrate 2mg/mL, the generic
for Roxanne’s Lorazepam Intensol® oral concentrate which had combined
brand and generic sales of $10 million for the 12 months ended December
2011 according to IMS sales data. The product is indicated for the
management of anxiety disorders or for the short-term relief of the
symptoms of anxiety or anxiety associated with depressive symptoms.
Hi-Tech plans to launch the product by May 2012.
Hi-Tech currently has 15 products awaiting approval at the FDA,
targeting brand and generic sales of over $1.5 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. 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