FDA approves Ranbaxy’s generic peptic ulcer treatment

PRINCETON, N.J. The Food and Drug Administration has given an India-based drug maker final approval to market a generic drug for treating peptic ulcer.

Ranbaxy Pharmaceuticals, a U.S. subsidiary of Ranbaxy Labs, announced Monday the approval of glycopyrrolate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Sciele Pharma’s Robinul and Robinul Forte tablets, respectively.

“We are pleased to receive this final approval for glycopyrrolate tablets,” Ranbaxy Pharmaceuticals VP sales and distribution Jim Meehan said in a statement.

Meehan said the drug would be launched between October and December. Glycopyrrolate tablets had sales of $26 million during the 12-month period ending in June, according to IMS Health data.