HEALTH

EU approves Pfizer’s pending acquisition of Wyeth

BY Michael Johnsen

NEW YORK Pfizer on Friday announced that the European Commission has approved under the European Union Merger Regulation the company’s pending acquisition of Wyeth. The commission’s decision includes Pfizer’s commitment to divest certain animal health assets in the European Union.

“We are pleased to have achieved another significant milestone for the pending acquisition with the EC’s approval of the transaction,” stated Amy Schulman, SVP and general counsel of Pfizer.

In addition, Pfizer announced that China’s Ministry of Commerce has extended its review of Pfizer’s regulatory submission beyond the initial thirty-day period. The completion of the transaction remains subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, governmental and regulatory approvals in certain other jurisdictions, and approval by the stockholders of Wyeth.

“We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close at the end of the third quarter or during the fourth quarter of 2009,” Schulman said.

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CDC: School children may need four immunizations this fall

BY Michael Johnsen

NEW YORK School children may need as many as four immunizations against both seasonal flu and the novel H1N1 virus this year, Centers for Disease Control and Prevention officials told clinicians Wednesday, according to published reports.

That regimen includes an initial shot and booster of both vaccines for children. Most everyone else will only need to get their regular seasonal shot and two shots for the novel H1N1 vaccine, when one is available.

Five manufacturers are currently producing vaccines against the pandemic H1N1 swine flu virus — CSL Biotherapies, GlaxoSmithKline, Medimmune, Novartis and Sanofi Pasteur.

The five manufacturers are expected to deliver between 40 million and 160 million doses of vaccine by October. The regular seasonal flu vaccine supply will be ready much earlier than usual, possibly as soon as late August.

According to CDC officials, pandemic flu shots will be allocated among states based on their population.

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Nature & Health announces voluntary, nationwide recall of five supplement products

BY Michael Johnsen

BREA, Calif. Nature & Health on Wednesday conducted a voluntary nationwide recall of the company’s five supplement products sold under the following names — LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule and Herbal Disiac — after being informed by the Food and Drug Administration that lab analyses of these five products found they contained either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction; its analog aminotadalafil; or the analog of sidenafil, another active ingredient of an FDA-approved ED drug.

None of the active drug ingredients are listed on the product labels. 

The undeclared ingredients may interact with nitrates found in such prescription drugs as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Additionally, the product may cause such side effects as headaches and flushing.

The recalled products were distributed in retail stores in California, Georgia, Illinois, Texas and Ohio.

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