Wyeth Receives FDA Approval Of Protonix For Delayed Release Oral Suspension

Main Category: Acid Reflux / GERD
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 18 Nov 2007 - 0:00 PDT

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Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced that the U.S. Food and Drug Administration (FDA) has approved Protonix® (pantoprazole sodium) For Delayed-Release Oral Suspension, a new addition to the Protonix family of prescription medications.

"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 gastroesophageal reflux disease (GERD)," says gastroenterologist Richard Lynn, MD, Senior Director, Global Medical Affairs for Wyeth Pharmaceuticals.

Protonix is one of the leading treatments for patients with erosive GERD. The addition of Protonix For Delayed-Release Oral Suspension builds upon the successful 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 Protonix Tablets.

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

The adverse reaction profile of Protonix For Delayed-Release Oral Suspension is similar to the established safety profile of Protonix Delayed-Release Tablets. In clinical trials, the most frequently reported adverse events with Protonix Delayed-Release Tablets were headache, diarrhea, and flatulence. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Protonix is contraindicated in patients with known hypersensitivity to any component of the formulation. Patients treated with proton pump inhibitors (PPIs) and warfarin concomitantly should be monitored for increases in INR and prothrombin time.

Wyeth Pharmaceuticals:

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas 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 and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people 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 are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, risk factors." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Wyeth Pharmaceuticals
http://www.wyeth.com