Law & Health Weekly
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Law & Health Weekly
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Chronic Pain
Cipher receives tentative FDA approval for extended-release tramadol capsules
March 7th, 2009
Cipher Pharmaceuticals Inc. (TSX: DND) announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, the Company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues related to the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized. "Tentative approval of our extended-release tramadol is another important achievement for our...
Source: Law & Health Weekly (2009-03-07)
|
