Hi-Tech Pharmacal granted final approval for generic Zantac syrup
AMITYVILLE, N.Y. — Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.
The drug maker said its abbreviated new drug application for ranitidine syrup in the 15-mg/mL strength was approved. Ranitidine syrup is a generic version of GlaxoSmithKline’s Zantac syrup, which garnered sales of $21 million for 12 months ended in December 2010, according to IMS sales data.
Hi-Tech currently has 13 products awaiting approval at the FDA, the company said.