SILVER SPRING Md. — The FDA has declined a new potential drug that would combine the Proteus system with Abilify, according to a report by Mobi Health News.
The drug is being developed as a collaboration between Proteus and Ostuka Pharmaceuticals, respectively.
The system was submitted to the FDA for approval in September 2015 with a swift approval reportedly expected. However, the FDA issued a Complete Response Letter (CRL) in response, detailing necessary steps the companies need to take to secure approval.
According to a statement by Proteus and Otsuka, the FDA requested data regarding the drugs performance in its intended environment and conditions. Additionally, a need for human factors investigations to identify human error risks and determine the safety and effectiveness of the drug were also requested.
Robert McQuade, executive vice president and chief strategy officer of Otsuka Pharmacuetical, said that “both Otsuka and Proteus are committed to working with the FDA to address its questions and provide the additional data that has been requested.”
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