Sicor Inc announced that its wholly owned subsidiary, Gensia Sicor Pharmaceuticals Inc, has received approval of an Abbreviated New Drug Application (ANDA) from the Food and Drug Administration (FDA) for propofol injection emulsion 1% in a 100 mg/10mL single use vial. Propofol is an intravenous sedative hypnotic agent used in the induction and maintenance of surgical anesthesia and to induce conscious sedation during certain diagnostic procedures.
According to IMS, a market research firm, total U.S. sales of propofol were approximately $375 million in 2001. The branded product, Diprivan, is marketed by Astra Zeneca Inc. Propofol is marketed and distributed by Baxter Healthcare Corporation, Sicor's marketing partner in the United States for certain anesthesia and critical care products.
"By listening to our customers, we continue to find better ways to deliver new and innovative products that benefit patients," said Marvin Samson, president and chief executive officer. "We believe that this new vial size will provide cost conscious users of this widely prescribed anesthetic agent with additional flexibility and convenience, especially in hospitals and clinics that perform shorter duration procedures. We are pleased to be able to provide value to clinicians in these new markets."