Hovione’s Technology Transfer Center (TTC) in New Jersey has passed successfully a pre-approval inspection by FDA. The three-day inspection was carried out by Ms. Joy R. Kozlowski-Klena, a compliance officer at FDA’s Center for Drug Evaluation and Research (CDER). No form 483 was issued. This inspection covered the center’s first commercial product, a high potency small molecule API for an injectable formulation. The NDA was filed in May and approval is expected in Q1 2008, ...