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FDA Approved 1,014 Generic Drugs in 2019

By Brian Orelli, PhD - Feb 19, 2020 at 2:58PM

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Approvals were down slightly year over year.

The Food and Drug Administration's Office of Generic Drugs had a productive 2019, approving 1,014 generic drugs, down ever so slightly from the 1,021 it approved in 2018. The 2019 figure includes 110 approvals for generic versions of complex drugs, which are harder to manufacture and typically have faced less generic competition.

The agency's annual report also notes that 108 of the approvals were for the first generic versions approved for their medications, including blockbusters such as Pfizer's (PFE 3.59%) Lyrica, Bristol-Myers Squibb's (BMY 0.30%) Eliquis, and GlaxoSmithKline's (GSK 2.20%) Advair.

Pills on $100 bills

Image source: Getty Images.

While those approvals were good news for generic drug makers, such as Teva Pharmaceutical (TEVA 1.93%), Mylan (MYL) and Novartis' (NVS 0.87%) Sandoz division, the office also issued a whopping 2,311 complete response letters (CRLs) -- nonapprovals in which it asks for more information or requests certain issues be resolved, after which it might reconsider an application. On the plus side, the number of CRLs was down from the 2,648 issued in 2018.

Over the last few years, the FDA stopped approving drugs on a first-in-first-out basis and began prioritizing applications for generic drugs in cases where there are less than two approved generics. "The FDA's data show that drug prices significantly decrease once there are at least three generic versions of the same brand name drug on the market," the report notes. The approval of generic Lyrica, for example, pushed the price of the drug from more than $7 per capsule for the branded drug to about $0.13 per capsule for the generic.

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Stocks Mentioned

Pfizer Inc. Stock Quote
Pfizer Inc.
$52.47 (3.59%) $1.82
Bristol Myers Squibb Company Stock Quote
Bristol Myers Squibb Company
$76.19 (0.30%) $0.23
Novartis AG Stock Quote
Novartis AG
$89.42 (0.87%) $0.77
GlaxoSmithKline plc Stock Quote
GlaxoSmithKline plc
$44.52 (2.20%) $0.96
Viatris Inc. Stock Quote
Viatris Inc.
Teva Pharmaceutical Industries Limited Stock Quote
Teva Pharmaceutical Industries Limited
$8.47 (1.93%) $0.16

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

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