After the phase 3 trial, the company seeks regulatory approval. They can start selling once the regulatory approval is granted.
In the USA, the FDA claims that it takes between 6 to 10 months to approve a New Drug Application (NDA) [1], but frequently it takes more than 12 months. It also takes a long time (anywhere from 2 to 12 months) for the company to prepare the NDA, which is a massive undertaking. So, in total the NDA + review process takes about 8-24 months. The timeline can vary in other countries.
Unlike other drugs, Nafithromycin has been approved as QIDP, so it will be processed under “Priority Review” [2] – we can be sure the review process will take less than 6 months [3]. The total time to market will depend on how fast the company can prepare the NDA. If they take 2 months, then the drug will come to the market within 8 months.
[1] Step 4: FDA Drug Review | FDA
[2] Priority Review | FDA
[3] 21 U.S. Code § 360n
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