Posted on 04/06/2009 in Pharmaceutical Company Product News Lilly believes the data it is submitting as part of its supplemental new drug application (sNDA) for Cymbalta (duloxetine HCl) will further strengthen its request.
The company had originally submitted the paperwork to the Food and Drug Administration (FDA) in the second quarter of 2008 but after discussing the study design and statistical methodology with the regulatory body, it decided to withdraw it.
Now the resubmission ? which Lilly had hoped would take place in the first half of this year ? is based on a recent study in chronic pain due to osteoarthritis.
Dr John Hayes, vice-president of the company's research laboratories, explained at the time of the initial application, the additional data about chronic osteoarthritis and low back pain was not available.
"We believe including these new data in the updated sNDA package will provide a broader clinical basis for the FDA to review the application," he said.
Last month, the European Medicines Agency's committee for medicinal products for human use granted Lilly with a positive recommendation for the administration of Almita (pemetrexed for injection) as a treatment for locally advanced or metastatic non-small cell lung cancer.Other news stories from 04/06/2009
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