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In 2019, the first generic approvals for lurasidone came from abbreviated new drug application (ANDA) filings that reached approval at the FDA. DrugPatentWatch.com tracks these “first approvals” as they occur. If you want the exact product names and FDA approval dates for the 2019 first generic lurasidone approvals, use DrugPatentWatch’s lurasidone page, which lists the first generic approval(s) tied to each NDA/ANDA entry and the corresponding timeline. [1]
For the FDA, a “first generic approval” generally means the earliest ANDA that the agency approves for a drug (including a specific strength or dosage form, depending on the FDA entry). Later ANDAs may follow, but the first one is the earliest time FDA grants approval for a generic version of that drug. DrugPatentWatch.com’s listings are useful for pinpointing which ANDA(s) were approved first and when. [1]
Often, yes. FDA approvals can be tied to specific strengths or formulations within the same active ingredient. The “first” generic approval date you see may apply to one strength/dosage form, while other strengths may be approved later in the same year or afterward. Checking the DrugPatentWatch lurasidone entry is the fastest way to confirm which specific generic products were approved first in 2019. [1]
[1] DrugPatentWatch.com – Lurasidone (generic approvals/timeline)
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