* Aims to launch generic version once has FDA approval
* Difficult to predict a timeline
(Adds detail from interview, background)
BASEL, Switzerland (Reuters) - Novartis is confident its generic copy of Sanofi-Aventis’s blockbuster anti-clotting drug Lovenox will gain U.S. approval, the head of its generics unit said on Tuesday, but gave no indication as to timings.
“We aspire to launch as soon as we have approval from the FDA (U.S. Food and Drug Administration),” Jeff George, CEO of Novartis’s generics unit Sandoz, told Reuters in an interview after Novartis posted fourth-quarter results. [ID:nLDE60P0RD]
George said it was hard to speculate on timing, but he was “cautiously optimistic” about the drug getting U.S. backing.
“We believe we have satisfactorily resolved all of the outstanding technical, regulatory and legal issues,” he said.
Last week, Novartis said it was making progress with a generic copy of Lovenox, after an analyst said the Swiss drugmaker was gearing up to launch its version.[ID:nLDE60L1US]
The news boosted shares of Novartis’s partner Momenta Pharmaceuticals Inc (MNTA.O), which soared more than 13 percent.
Along with Novartis/Momenta, others seeking approval for a generic Lovenox include Teva Pharmaceutical Industries Ltd (TEVA.TA) and a partnership of Watson Pharmaceuticals Inc WPI.N and privately held Amphastar Pharmaceuticals. (Reporting by Sam Cage and Katie Reid, editing by Will Waterman)