Solvay Pharmaceuticals, Inc. Announces Commercial Availability of CREON(R) (Pancrelipase) Delayed-Releas...(ld take note. CREON(R) is the first ze...),Health

Date:7/7/2009

ld take note. CREON(R) is the first "zero-overfill" pancreatic enzyme product, meaning that the capsules target 100% of the lipase amount indicated on the product labeling. Mineral oil has also been removed from the product, which may lead to increased absorption of fat-soluble vitamins. Additionally, the product has new trade dress and capsule imprints to distinguish the former dosage strength capsules from this new FDA-approved formulation.

To ensure that patient access to CREON(R) is not disrupted, the former dosage strengths of CREON(R) will continue to be commercially available during a brief transitional period while Solvay Pharmaceuticals educates healthcare professionals, patients and caregivers about the transition to FDA-approved CREON(R). Effective July 7th, however, prescribers and pharmacists should begin writing and filling CREON(R) prescriptions reflecting the new, FDA-approved dosage strengths as CREON(R) 5, 10 and 20 will no longer be sold to wholesale distributors. Additional information about the new formulation of CREON(R) can be found at www.CREON.com.

"We are proud that CREON(R) is the first and only pancreatic enzyme product to receive FDA approval and to meet the FDA's standards of quality, safety, effectiveness and labeling," said Elizabeth Mutisya, M.D., Vice President of Medical Affairs and Chief Medical Officer, Solvay Pharmaceuticals. "Solvay Pharmaceuticals is committed to helping healthcare professionals, patients and their caregivers transition to the FDA-approved formulation of CREON(R) and to continuing our more than 20 years of support for patients with EPI."

Solvay Pharmaceuticals offers a Patient Assistance Program through which certain patients can obtain CREON(R) at no cost if they meet financial eligibility criteria. Solvay Pharmaceuticals also offers a CF-specific support program, SolvayCARES(SM), which provides n
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SOURCE Solvay Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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