GlaxoSmithKline Recalling Ventolin Inhalers for Possible Package Leakage

GlaxoSmithKline (GSK) issued a voluntary Class II recall on April 4, 2017 for three lots of Ventolin® HFA 200D Inhalers from U.S. hospitals, pharmacies, retailers and wholesalers as a precautionary measure. It is not a consumer recall.

The lot numbers are:

·         6ZP0003

·         6ZP9944

·         6ZP9848

A GSK spokesman spoke with AAFA and said the recall is due to some complaints about the overwrap, or pouches containing the inhalers, becoming inflated by leaking from the product. The leaking may cause the inhaler to deliver fewer doses than shown on the dose counter. 

Patients are not being told to return the inhalers. If you have a question, call the company’s response center: 1-888-825-5249.

A Class II recall is one where "use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the U.S. Food and Drug Administration.

The company released a statement that said, “Though the overall benefit-risk assessment for Ventolin® HFA 200D Inhaler when used at prescribed doses remains favourable, in this situation, there is possible risk to patients of experiencing diminished bronchodilation in the setting of acute bronchospasm if reliant on a rescue inhaler that could potentially not deliver the stated number of actuations. GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this recall may cause."

If you need to fill a prescription for Ventolin HFA 200D, the voluntary recall should not affect pharmacy supplies. 

Source: AAFA

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GSK files potential $1 billion shingles vaccine for U.S. approval

Shingrix is viewed by analysts as among the British company's most promising experimental products, since it has shown greater protection among older recipients than Merck & Co's rival shot Zostavax.

By Ben Hirschler

LONDON: GlaxoSmithKline has filed its shingles vaccine Shingrix for U.S. regulatory approval, the drugmaker said on Monday, bringing the potential $1 billion-a-year seller a step closer to market.

Shingrix is viewed by analysts as among the British company's most promising experimental products, since it has shown greater protection among older recipients than Merck & Co's rival shot Zostavax.

GSK itself highlighted Shingrix as one of its top near-term pipeline hopes last November, during its first research and development day in more than a decade.

The company, which will see Emma Walmsley take over as chief executive in 2017, is seeking to revitalise a drug portfolio hit by falling sales of best-selling inhaled lung treatment Advair.

In clinical trials, GSK's vaccine remained 90 percent effective in people over age 70, even four years after injections. Zostavax efficacy, by contrast, varies between 18 and 70 percent, and it declines noticeably in older people.

People who are 70 years or older are often most at risk from shingles, a painful, itchy rash that results from the reactivation of latent chickenpox virus.

The impressive trial results should put Shingrix in a strong competitive position, analysts believe, even though it requires two doses, against just one for Zostavax, and it is also linked to more injection site reactions.

Analysts, on average, predict that worldwide sales of Shingrix will reach 856 million pounds ($1.05 billion) in 2021, according to consensus forecasts compiled by Thomson Reuters.

Sales of Zostavax, the only shingles vaccine on the market at present, totalled $749 million in 2015.

GSK's vaccine contains a component from U.S. biotech firm Agenus, which is entitled to royalties on future sales.

GSK said it planned to file Shingrix for European and Canadian approval before the end of this year, with Japan following in 2017.

($1 = 0.8191 pounds)(Editing by Susan Fenton and Jason Neely)

www.gmpviolations.com (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed.)

 Disclaimer: The Logos/Images posted here are belongs to respective to Authority / owners of firm.

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