Cipher Pharmaceuticals has received US Food and Drug Administration approval for its extended-release tramadol product CIP-TRAMADOL ER to treat chronic pain in adults.
The product is an immediate-release tablet with sustained-release beads and has no food effect.
Cipher is in the process of finalising a commercial manufacturer and a marketing partner for the drug.
The drug launch will also be influenced by the outcome of the case involving Purdue Pharma’s appeal against Par Pharmaceutical relating to Orange Book-listed patents for Ultram ER, Cipher’s new drug application reference product.
A decision in the case is expected late this year.
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