PHARMACY

Sanofi Pasteur ships first doses of Fluzone

BY Michael Johnsen

SWIFTWATER, Pa. Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, on Monday announced that it has shipped the first doses of the 2009-2010 formulation of Fluzone, a vaccine for seasonal influenza.

Fluzone vaccine is indicated for active immunization in people 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the seasonal influenza vaccine. Fluzone vaccine is the only vaccine licensed in the United States for children as young as 6 months of age through adults.

In total, Sanofi Pasteur expects to supply over 50 million doses of Fluzone vaccine to the U.S. for the 2009-2010 season.

The CDC recommends that healthcare providers begin their immunization efforts for seasonal influenza as soon as vaccine is available and continue their immunization efforts throughout the entire influenza season. Immunization for seasonal influenza remains a public health priority. On average each year, one out of five Americans suffers from seasonal influenza, approximately 226,000 are hospitalized and 36,000 die from influenza-related complications.

The vaccine formulation for the 2009-2010 season contains three strains of the influenza virus: the A/Brisbane/59/2007 (H1N1)-like virus; the A/Brisbane/10/2007 (H3N2)-like virus; and the B/Brisbane/60/2008-like virus. The seasonal influenza vaccine does not incorporate the A/California/7/2009(H1N1) virus strain of the novel A(H1N1) influenza and is not expected to offer protection against this new type of influenza. Sanofi Pasteur is working with the WHO and the CDC on the development of a separate vaccine for the novel A(H1N1) influenza, commonly referred to as the new “swine” influenza.

Approximately 260 million people, or four out of five residents of the U.S. are recommended to receive the influenza vaccine annually. The CDC recommends an annual influenza immunization for all children 6 months through 18 years of age; adults over 50 years of age; pregnant women; anyone with chronic health conditions, such as asthma, chronic obstructive pulmonary disease, heart disease, and diabetes; as well as caregivers and household contacts of these high-risk groups, such as relatives and health-care providers. The CDC also recommends annual immunization for anyone who wishes to reduce their risk of contracting influenza.

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Taro files patent infringement suit against three companies

BY Alaric DeArment

HAWTHORNE, N.Y. An Israeli generic drug maker has sued three other companies, alleging patent infringement.

Taro Pharmaceutical Industries announced Monday that it had filed suit in the U.S. District Court for the District of New Jersey against Synerx Pharma, DPT Labs and Karalex Pharma, alleging infringement of U.S. Patent No. 7,560,445. The patent covers Taro’s Ovide (malathion) lotion in the 0.5% strength, a treatment for head lice.

Taro said the defendants’ generic versions of the drug infringed its patent, and it’s seeking injunctive relief and damages.

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News article calls Mylan’s quality control into question; company responds

BY Alaric DeArment

PITTSBURGH A news article published over the weekend calling generic drug maker Mylan’s manufacturing into question has drawn a response from the company.

The Pittsburgh Post-Gazette reported Sunday that workers at the company’s Morgantown, W.Va., plant overrode drug quality controls required by the government by ignoring and deleting computer warnings of possible drug quality or equipment problems, based on a confidential internal report obtained by the newspaper’s reporters that called it a “pervasive” problem. Normally the warnings, known as “red screens,” require production to halt until a quality-control agent can investigate the matter.

The company responded by saying in a statement Monday that the Post-Gazette article was based on anonymous sources, improperly obtained documents and third-party commentary.

“Our customers and stakeholders can rest assured that whenever there is even the slightest departure from [a standard operating procedure], it will be dealt with immediately and effectively,” the company said in a statement. “This issue had no impact on the quality of our product.”

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