LI firm gets FDA OK on 2 nonseasonal drugs

Hi-Tech Pharmacal Co. Inc., the Amityville maker of generic drugs, is moving away from a reliance on sales of drugs that ease the winter blahs and opening up its range of drugs to treat allergies and nonseasonal maladies.

"Historically, the months of September through March account for a greater portion of the company's sales than the other months of the fiscal year," Hi-Tech Pharmacal said in its latest quarterly report, issued March 14.

"However, this sales pattern is unlikely to continue as the company sells fewer cough and cold products, more allergy products and more products without seasonal fluctuations," the company said.

Thursday Hi-Tech announced it has gotten FDA approval to sell new generic versions of two nonseasonal drugs: the ulcer treatment Zantac and the local anaesthetic Xylocaine.

The generic for GlaxoSmithKline's Zantac that the Food and Drug Administration granted final approval for Hi-Tech to sell is ranitidine syrup. The potential annual market for the syrup, a treatment for heartburn or acid reflux, is about $21 million, Hi-Tech said.

The generic for APP Pharmaceuticals' Xylocaine that the FDA gave Hi-Tech the okay to sell is lidocaine HCl jelly, which represents a potential $17-million annual sales market, Hi-Tech said.

Hi-Tech has 12 products awaiting approval at the FDA, targeting brand and generic sales markets of about $1 billion, the company said.

It also has 20 products in active development targeting brand sales of more than $3 billion, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.

Hi-Tech, which trades on the Nasdaq, has a market capitalization of $248 million, with net income of $34 million on $175 million in revenue in the past 12 months. Its stock dipped 9 cents, or .46 percent, to $19.68 in trading Thursday.