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Biotech / Medical : Techniclone (TCLN) -- Ignore unavailable to you. Want to Upgrade?

To: EZLibra who wrote (2944)	3/9/1999 9:44:00 PM
From: WE89	Read Replies (1) \| Respond to of 3702

Is this the same company we just made a deal with. FDA says Schering delayed drug reaction reports WASHINGTON, March 9 (Reuters) - German drug maker Schering AG <SCHG.F> delayed reporting serious reactions to three of its products by as much as two years, the Food and Drug Administration has charged. In a warning letter released Tuesday, the agency charged that Schering did not immediately report the incidents to its New Jersey subsidiary, Berlex Laboratories, which was charged with notifying the FDA. Drug companies are required by law to tell FDA about serious reactions within 15 days. In one case, a patient given Ultravist, a contrast agent, went into shock so severe it was considered life-threatening, the letter said. Schering learned of the incident in August 1996 but did not notify Berlex until September 1998, the letter said. Another patient suffered shock and required a long hospital stay after receiving the contrast agent Magnevist, said the letter, which was sent Feb. 25. Other patients had severe reactions to Fludara, a treatment for chronic lymphocetic leukemia. The FDA's letter did not give details on those incidents. Berlex notified the FDA within a day or two of receiving information from Schering, the letter said. The two companies are training staff members and taking other actions to make sure reporting requirements are followed, a Berlex spokeswoman said. The reporting deficiencies were discovered during an FDA inspection of Berlex facilities in 1998, the spokeswoman said. "We are now in the process of working with Schering to verify that the correct actions have been taken," said Berlex spokeswoman Wendy Neininger. 20:09 03-09-99