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Sicor gets tentative ANDA approval for adenosine injection

CaliforniaSaturday, September 27, 2003, 08:00 Hrs  [IST]

Sicor Inc announced that the Food and Drug Administration (FDA) has issued a tentative approval of an Abbreviated New Drug Application (ANDA) submitted by its wholly owned subsidiary, Sicor Pharmaceuticals Inc, for adenosine injection. Adenosine is indicated for conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). The Company expects to receive final approval upon the patent expiration in June 2004. According to IMS, a market research firm, U.S. sales of adenosine were approximately $35 million in 2002. The branded product, Adenocard, is marketed by Fujisawa Healthcare Inc.

 
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