The Food and Drug Administration (FDA) has determined the regulatory review period for the drug XTAMPZA ER, which is used for managing severe pain requiring long-term opioid treatment. This review is necessary for a possible extension of the drug's patent, as requested by Collegium Pharmaceutical, Inc. The review period comprises 3,214 days, with 2,712 days for testing and 502 days for approval. The FDA invites comments on this determination and allows for petitions if there are disagreements concerning the information or the due diligence during the review process.
Simple Explanation
The FDA checked how long it took to approve a special medicine called XTAMPZA ER, used for pain, to see if they can give it more time before others can copy it. People can say if they agree or disagree with how the FDA measured this time.