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Hi-Tech Pharmacal gets OK for generic ulcer drug

Hi-Tech Pharmacal chief executive David Seltzer visits the

Hi-Tech Pharmacal chief executive David Seltzer visits the sterile packaging area in the Amityville plant. (June 3, 2003) Photo Credit: Pablo Garcia Corradi, 2003

Amityville-based Hi-Tech Pharmacal Co. Inc. has gotten federal approval to sell a generic version of Zantac syrup, a treatment for duodenal ulcers.

The U.S. Food and Drug Administration granted final approval for ranitidine syrup, the generic for GlaxoSmithKline’s Zantac.

The potential annual market for ranitidine syrup, a treatment for heartburn or acid reflux, is about $21 million, the company said.

Ranitidine is a histamine-2 receptor antagonist (a group often called H2 blockers) that is prescribed to reduce stomach acid. These include cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid) and ranitidine (Zantac).

A report in December indicated that popular acid-reduction drugs, including proton pump inhibitors and histamine-2 receptor antagonists, may raise the risk of pneumonia.

Photo: Hi-Tech Pharmacal chief executive David Seltzer visits the sterile packaging area in the Amityville plant.

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