Active Pharmaceutical Ingredient Watch

21 October 2002 00:00  [Source: ICB Americas]

ABBOTT LABORATORIES received Food and Drug Administration (FDA) approval to reintroduce Abbokinase (urokinase) to treat pulmonary embolism. Abbokinase is a thrombolytic therapy used to dissolve blood clots.

AKZO NOBEL saw its shares decline 10 percent on news of a one-year delay in the regulatory filing of antidepressant drug Gepirone ER, developed by the company's human health care unit Organon. Organon will submit data required by the FDA in the third quarter of 2003 and aims for a 2004 launch.

ASTRAZENECA PLC is collaborating with the Japanese Ministry of Health Labor and Welfare to make revisions to the label of lung cancer drug Iressa (gefinitib) as a precautionary approach to bring greater prominence to an already known side effect, interstitial pneumonia.

BRISTOL-MYERS SQUIBB Company (BMS) has received an approvable letter from the FDA for Vanlev (omapatrilat). The letter recommends BMS conduct at least one additional clinical trial.

FOREST LABORATORIES Inc. posted fiscal second quarter 2003 net income up 79 percent to $143 million, or 77 cents per share, 3 cents ahead of revised Banc of America estimates, on strong sales of Celexa (citalopram).

GLAXOSMITHKLINE PLC (GSK) received FDA approval for Avandamet (rosiglitazone maleate and metformin) to treat Type 2 diabetes, a combination of its Avandia with generic metformin.

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