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Hi-Tech Pharmacal gets approval for epilepsy drug

Hi-Tech Pharmacal employees at the Amityville plant in

Hi-Tech Pharmacal employees at the Amityville plant in 2010. Credit: Tom Decker, 2010

Hi-Tech Pharmacal, of Amityville, has received final FDA approval for a generic drug to treat certain epileptic seizures.

The product, Levetiracetam oral solution, is prescribed for partial onset epileptic seizures, and the company plans to bring it to market by May.

It is a generic form of the branded drug Keppra, made by UCB Pharma. The combined market last year totaled $62 million for the branded and generic forms of the drug, Hi-Tech Pharmacal said in a Wednesday news release.

Hi-Tech Pharmacal said Wednesday that it is seeking Food and Drug Administration approval for 14 other products. It said those products have an annual combined brand-name and generic market of more than $1.5 billion.

The company said it also has 20 more products in active development, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays. These 20 products, if developed and approved, would compete for a share of a combined generic and brand-name annual market of $3 billion, Hi-Tech said.

In early trading Wednesday Hi-Tech's stock was up 20 cents, to $40.68, with a 52-week range of $18.68-$44.58. With about 400 workers, the company has a market capitalization of about $530 million.

Photo: Hi-Tech Pharmacal employees at its Amityville plant.

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