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A tentatively approved drug is a drug filed with the FDA and considered complete but waiting for some trigger for full approval. The trigger is typically a future patent expiry date or exclusivity date. Understand who has tentative drug approvals and who may enter the market soon.
Tentative drug approvals help payers know who may be entering the market so they can adjust their payment tiers, partners or other items.
News of tentatively approved drugs can impact the wholesalers stocking plan or inventory strategy for a pharmaceutical drug.
Information on tentatively approved drug can inform pharma companies of future entrants that may impact thier go to market staregy or inform business development experts of companies that may be looking for a partner to bring a tentatively approved drug to themarket.
Wizmed runs a scan of tentatively approved drugs weekly, of this is faster than the source data from the FDA is updated. For example, let's say you wanted to research a drug on who has FDA approval as welll as tentative approval. You can an see the FDA approvals and tentative approvals in our one search. Click here for a Dexmedetomidine example.
Recent FDA Warning Letters