Wyeth receives FDA approval for Protonix

Wyeth Pharmaceuticals, a division of Wyeth, has announced that the US Food and Drug Administration (FDA) has approved its Protonix For Delayed-Release Oral Suspension in patients with erosive gastroesophageal reflux disease (GERD).

The FDA’s approval brings a new addition to the Protonix range of prescription medications, with the novel suspension joining Protonix Delayed-Release Tablets and Protonix IV For Injection.

Richard Lynn, senior director of Global Medical Affairs for Wyeth Pharmaceuticals, confirmed: “The availability of Protonix For Delayed-Release Oral Suspension provides adult patients who cannot swallow tablets with an effective and convenient way to treat their erosive GERD.”

Protonix For Delayed-Release Oral Suspension is indicated for the treatment and maintenance of erosive esophagitis with associated GERD symptoms and is administered orally in apple sauce or apple juice or through a nasogastric tube.

The new suspension provides similar acid suppression to Protonix tablets as well as having a comparable safety profile.

In clinical trials for Protonix tablets, headaches, diarrhoea and flatulence were cited as the most common side effects.

Last month, Wyeth announced that its supplemental New Drug Application for Tygacil (tigecycline) had been accepted by the FDA in patients with community-acquired pneumonia.