PHARMACY

U.S., China near agreements on food, drug safety standards

BY Jim Frederick

WASHINGTON Health and Human Services Secretary Michael Leavitt announced Monday the United States and China will soon ratify a set of agreements aimed at ensuring that medicines, food, medical devices and other products made in China will meet the standards set by the Food and Drug Administration.

“Early next week, we hope to sign binding memorandums of understanding in the areas of food and feed and devices and drugs,” Leavitt said in a speech to the U.S. Chamber of Commerce,” according to the China View news agency.

The announcement follows a string of high-profile recalls of Chinese products deemed unsafe for consumption or use, and a wholesale reassessment of that vast nation’s safety standards by American officials and consumers. In the wake of those revelations, China’s leaders have launched a massive campaign to rid the nation’s manufacturing and safety oversight procedures of corruption and ineffective leadership, even going so far as to execute the official in charge of food and drug safety earlier this year.

During a visit to China in October, Leavitt defended China’s efforts to boost drug safety procedures. “Their systems are relatively new compared to ours. And yet at the same time they have made an enormous amount of progress as it relates to their development of infrastructure,” Leavitt asserted. “And they are as concerned about confidence in the quality and safety of food and drugs as we are in the United States.”

Subsequent to that visit, a number of Chinese officials in charge of food and drug safety in that country met in Washington with FDA representatives.

Noting what he called “the radical changes that were occurring in the world around us,” Leavitt added, “we needed to … rethink our strategy for continuing to ensure the quality and safety of the drugs and medical devices and the food that we were importing.”

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Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue

BY Allison Cerra

NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.

While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.

At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.

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Caraco receives tentative FDA approval for generic Lexapro

BY Allison Cerra

WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.

“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”

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