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.