Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Salix Pharmaceuticals stock rose 5 percent last week despite news that the company received a warning letter from the Food and Drug Administration (FDA) urging the company to clarify information about its new orally dissolving heartburn treatment, Metozolv ODT, according to Local Tech Wire. The FDA said that some of the drug’s marketing materials are “false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”

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The Food and Drug Administration (FDA) has fired off a warning letter to drug maker Salix Pharmaceuticals arguing that some of its marketing materials for Metozolv, an orally dissolving form of metoclopramide for the treatment of acid reflux conditiosn, “are false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”

The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

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The Food and Drug Administration (FDA) has approved a generic version of a drug for treating gastroesophageal reflux disease, or GERD, in adolescents and adults. Amneal Pharmaceuticals’ nizatidine oral solution was approved in the 15-mg-per-15-ml strength, and is a generic version of Axid, made by Braintree Laboratories. The medication belongs to a class of drugs known as histamine H2 blockers.

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Be your own advocate. That is what the Gastroparesis, etc… blogger suggests for people, like her, who suffer from gastroparesis, a condition in which the stomach takes too long to empty its contents. The blogger can be found at gpadvocate.wordpress.com.

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Salix Pharmaceuticals, Ltd., makers of medicines for various gastrointestinal ailments, has received marketing approval from the Food and Drug Administration (FDA) for Metozolv ODT for the treatment of both diabetic gastroparesis and symptomatic documented GERD. Metozolv ODT is an orally disintegrating metoclopramide tablet. Metoclopramide was previously only available in the United States in a pill form under the brand name Reglan.

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