BERLEX LABS HAS NDAs FOR TWO IMAGING AGENTS PENDING AT FDA
Executive Summary
BERLEX LABS HAS NDAs FOR TWO IMAGING AGENTS PENDING AT FDA, the company told "The Pink Sheet." Applications for the myelographic agent iotrolan and gadolinium DPTA, a contrast agent for use in the magnetic imaging of head and neck lesions, were filed with the agency in February and August, respectively. Berlex explained that the two filings are indicative of the firm's increased emphasis on diagnostic imaging. Both compounds were initially developed by Berlex' West German parent, Schering AG. According to the company, gadolinium DPTA is the first contrast agent for magnetic resonance imaging, and the U.S. is the first country in which regulatory approval is being sought. In addition, Berlex has two anti-arrhythmic drugs in clinical study -- CK 1752, a compound developed in-house which should be in Phase II by year end, and dipraphenone, a product licensed from the German firm Helopharm and currently in Phase II. Also in Phase II is the prostacycline compound, iloprost, for use in cardiopulmonary bypass surgery.
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BERLEX LABS HAS NDAs FOR TWO IMAGING AGENTS PENDING AT FDA, the
company told "The Pink Sheet." Applications for the myelographic
agent iotrolan and gadolinium DPTA, a contrast agent for use in the
magnetic imaging of head and neck lesions, were filed with the
agency in February and August, respectively. |