Drug Development

Esmolol hydrochloride injection approved for control of ventricular rate

Published in Medical Letter on the CDC and FDA, June 5th, 2005

American Pharmaceutical Partners, Inc., (APP, APPX) announced that it has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Esmolol Hydrochloride Injection, 10 mg/mL, the generic equivalent of Baxter International's Brevibloc Injection.

According to IMS, sales of Esmolol 10 mg/mL were $16.5 million in 2004. APP expects to commence marketing this product immediately.

Esmolol is the fourth product approval APP has received in 2005.

Esmolol is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in...

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Source: Medical Letter on the CDC and FDA (2005-06-05)

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