Although Zyflo has been approved for sale since 1996, Critical has not been able to launch the drug due to manufacturing problems. The company is still in the process of changing manufacturing sites and is currently waiting for the FDA to approve alterations.
Critical said it expects the drug to be available for sale by December this year. The news caused shares in Critical to rise by 10%.
Critical has said it will contract at least half of the US manufacturing to Patheon who have experience of making the drug. Patheon manufactured Zyflo both for use in clinical trials and for its regulatory review. The deal will initially last for three years with automatic one-year extensions thereafter unless the companies give notice to end the contract.
Zyflo tablets are approved to treat asthma symptoms and decrease the number of acute attacks.