The once daily tablet, Gralise is developed by Depomed and it is licensed to Abbott Products in US, Mexico and Canada.
Depomed CEO Carl Pelzel said the approval of Gralise is a major step toward achieving their key strategic objective of sustainable profitability in 2011 and beyond.
Depomed Research and Development vice president Michael Sweeney said FDA has granted Gralise Orphan Drug status, recognizing Gralise as an important treatment option for patients who suffer from the pain of PHN.