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news.The US Food and Drug Administration (FDA) has announced that the agency will take more time to review the Salix Pharmaceuticals' new drug application (NDA) for crofelemer 125 mg tablets.
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Crofelemer is designed to provide symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
Salix chief development officer and medical, research and development executive vice president Bill Forbes said by taking no action at the prescription drug user fee act goal date time, the FDA has allowed for the currently ongoing dialogue between the company and the FDA to continue.
"The continuing dialogue should allow further collaboration between us and the Agency, a collaboration that has resulted in substantial progress in handling topics important to crofelemer as well as to botanical products in general," Forbes added.
"The primary topic is the production and control of the crofelemer active pharmaceutical ingredient, a complex mixture that is the first botanical product to be reviewed by the Agency for oral use.
"We look forward to this continuing collaboration, and at this time anticipate an action by the FDA on our NDA by the end of the first quarter of 2013."