FDA gives tentative approval to generic hypertension drug
MORRISTOWN, N.J. — Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.
The company said the FDA had given tentative approval to guanfacine extended-release tablets in the 1-mg, 2-mg, 3-mg and 4-mg strengths, a generic version of Shire's Intuniv. Tentative approval means a generic drug meets the basic regulatory requirements for final FDA approval, but the FDA can't approve it because the patents covering the branded version have not yet expired. Actavis said it was likely the first company to file an application for generic Intuniv with a paragraph IV certification, a legal assertion that one or more patents covering Intuniv are invalid, unenforceable or not in danger of being infringed.
Intuniv had sales of about $342 million during the 12-month period ended in March, according to IMS Health.