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Wyeth Receives FDA Approval of Protonix for Delayed-Release Oral Suspension

Friday, November 16, 2007 General News
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COLLEGEVILLE, Pa., Nov. 15 WyethPharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that theU.S. Food and Drug Administration (FDA) has approved Protonix(R) (pantoprazolesodium) For Delayed-Release Oral Suspension, a new addition to the Protonixfamily of prescription medications.
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"The availability of Protonix For Delayed-Release Oral Suspension providesadult patients who cannot swallow tablets with an effective and convenient wayto treat their erosive gastroesophageal reflux disease (GERD)," saysgastroenterologist Richard Lynn, MD, Senior Director, Global Medical Affairsfor Wyeth Pharmaceuticals.
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Protonix is one of the leading treatments for patients with erosive GERD.The addition of Protonix For Delayed-Release Oral Suspension builds upon thesuccessful Protonix family of products, which also includes Protonix Delayed-Release Tablets and Protonix I.V. For Injection. The new Protonix For Delayed-Release Oral Suspension provides comparable acid suppression to ProtonixTablets.

Protonix For Delayed-Release Oral Suspension can be administered orally inapplesauce or apple juice, or through a nasogastric (NG) tube. Protonix ForDelayed-Release Oral Suspension is indicated for the treatment and maintenanceof healing of erosive esophagitis with associated gastroesophageal refluxdisease (GERD) symptoms. Controlled studies did not extend beyond 12 months.

The adverse reaction profile of Protonix For Delayed-Release OralSuspension is similar to the established safety profile of Protonix Delayed-Release Tablets. In clinical trials, the most frequently reported adverseevents with Protonix Delayed-Release Tablets were headache, diarrhea, andflatulence. Symptomatic response to therapy does not preclude the presence ofgastric malignancy. Protonix is contraindicated in patients with knownhypersensitivity to any component of the formulation. Patients treated withproton pump inhibitors (PPIs) and warfarin concomitantly should be monitoredfor increases in INR and prothrombin time.

Wyeth Pharmaceuticals:

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in theareas of women's health care, infectious disease, gastrointestinal health,central nervous system, inflammation, transplantation, hemophilia, oncology,vaccines and nutritional products.

Wyeth is one of the world's largest research-driven pharmaceutical andhealth care products companies. It is a leader in the discovery, development,manufacturing and marketing of pharmaceuticals, vaccines, biotechnologyproducts and nonprescription medicines that improve the quality of life forpeople worldwide. The Company's major divisions include Wyeth Pharmaceuticals,Wyeth Consumer Healthcare and Fort Dodge Animal Health.

The statements in this press release that are not historical facts areforward-looking statements based on current expectations of future events andare subject to risks and uncertainties that could cause actual results todiffer materially from those expressed or implied by such statements. Theserisks and uncertainties include the inherent uncertainty of the timing andsuccess of, and expense associated with, research, development, regulatoryapproval and commercialization of our products, including with respect to ourpipeline products; government cost-containment initiatives; restrictions onthird-party payments for our products; substantial competition in ourindustry, including from branded and generic products; data generated on ourproducts; the importance of strong performance from our principal products andour anticipated new product introductions; the highly regulated nature of ourbusiness; product liability, intellectual property and other litigation risksand environmental liabilities; uncertainty regarding our intellectual propertyrights and those of others; difficulties associated with, and regulatorycompliance with respect to, m
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