HEALTH

FDA approves generic OTC allergy medication

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of an OTC allergy drug, FDA records show.

The agency approved Anmeal Pharmaceuticals’ cetirizine hydrochloride syrup in the 5 mg-per-5 milliliter strength.

The drug is a generic version of Johnson & Johnson’s Zyrtec. Amneal is the 10th company to gain FDA approval for a generic version of the drug. J&J switched Zyrtec from a prescription to an OTC drug last year.

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CDC refutes reports that influenza vaccine poses risk of developing H1N1

BY Michael Johnsen

ATLANTA The Centers for Disease Control and Prevention on Wednesday played down recent media reports describing unpublished findings from seasonal influenza vaccine studies conducted in Canada.

The findings from these studies suggest that receiving the 2008-09 seasonal influenza vaccine (which is the vaccine offered last influenza season) was a risk factor for developing influenza caused by the 2009 H1N1 virus. In the studies done in Canada, the increase in risk among persons vaccinated with a seasonal influenza vaccine was approximately double the risk for those who were not vaccinated with seasonal influenza vaccine.

“However, the research findings from Canada have not been published in the medical literature or presented at any public scientific meetings. There has not yet been an opportunity to fully review the studies in detail,” CDC stated.

“Preliminary results of studies conducted in the United States using methods similar to the Canadian studies did not indicate that receiving a seasonal influenza vaccine increased the risk of developing influenza caused by the 2009 H1N1 influenza virus,” the agency added. “No other country has reported that seasonal influenza vaccine increases the risk of developing influenza caused by the 2009 H1N1 influenza virus.”

One one study has been published on this issue — an Australian study that did not find any association between receipt of seasonal influenza vaccine and risk of developing influenza caused by the 2009 H1N1 influenza virus.

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Florastor products to be sold at CVS/pharmacy

BY Michael Johnsen

SAN BRUNO, Calif. As part of its continued expansion throughout the U.S. retail market, Biocodex, the U.S. distributor of Florastor and Florastor Kids, has secured distribution through CVS/pharmacy beginning this month, the company announced. Florastor will be placed on-shelf in the stomach/digestives aisle, while Florastor Kids will be available upon request behind the counter.

According to Dan Harper, director of sales for Biocodex, the stomach/digestives aisle is the most appropriate spot for this product – in the company of popular anti-diarrheal remedies.

“While Florastor is technically a dietary supplement, it is used successfully by many to manage digestive ailments and diarrhea, so it makes sense for it to be available in the section where the consumer will be looking for those types of items,” Harper said.

“When Florastor was first introduced to Americans, the idea of probiotics was not well understood by mainstream consumers or even traditional medical practitioners,” stated Marc Rohman, U.S. VP and GM of Biocodex. “However, as Americans are becoming increasingly aware of the benefits of probiotics, particularly yeast-based probiotics such as Florastor, expanding distribution into the chain stores was the next logical step to meet the demand we’re seeing.”

According to Rohman, sales of Florastor have grown annually, even without widespread on-shelf availability, as a result of increased pharmacist and consumer awareness of the probiotic category, word-of-mouth and physician recommendations.

The latest chain shelf space acquisitions are the result of Biocodex’s work with Morgan & Sampson USA, with which Biocodex teamed to help manage its growth and distribution within the U.S. retail trade.

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