Fiscal year 2019 was a record-breaking one, according to the FDA. The US regulator smashed its previous total for annual generic drug approvals with 1,171 positive reviews completed that year, comprising 935 approvals and 236 tentative approvals.
Furthermore, of this total, 125 approvals were the first generic versions of their respective reference products, meaning there was no previous generic competition prior to the FDA’s ruling.
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