In 2017, CDER approved a wide variety of drug therapies to improve the health of the American public, including:
• Novel drugs, which are often among the more innovative products in the marketplace, and/or help advance clinical care by providing therapies never before marketed in the United States;
• New and expanded uses for already FDA-approved drugs;
• Biosimilars, which are highly similar to already FDAapproved therapeutic biological products. These approvals add consumer choice and marketplace competition;
• New formulations or new manufacturers of already FDA-approved products that can provide advantages over original products, such as being able to take the drug on an empty stomach instead of with food, and;
• New dosage forms that can add value to already FDAapproved drugs, such as chewable tablets for patients unable to swallow pills. This report summarizes these approvals and highlights examples, emphasizing those approvals that offer new and innovative treatments to patients in need.
Novel Drugs
Novel drugs are often innovative products that serve previously unmet medical needs or otherwise significantly help to advance patient treatments. The active ingredient or ingredients in a novel drug have never before been approved in the United States. This report lists all of CDER’s novel drug approvals of 2017 and also discusses those that CDER considers notable advances. In 2017, CDER approved 46 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics License Applications (BLAs).
CDER’s Novel Drug Approvals of 2017
CDER’s novel drug approvals for 2017 are listed below.* See CDER’s Novel Drug Approvals for 2017 on the FDA website for the approval dates, non-proprietary names, and what each drug is used for.
|
Aliqopa |
Brineura |
Imfinzi |
Ocrevus |
Solosec |
Vosevi |
|
Alunbrig |
Calquence |
Ingrezza |
Ozempic |
Steglatro |
Vyzulta |
|
Austedo |
Dupixent |
Kevzara |
Parsabiv |
Symproic |
Xadago |
|
Bavencio |
Emflaza |
Kisqali |
Prevymis |
Tremfya |
Xermelo |
|
Baxdela |
Fasenra |
Macrilen |
Radicava |
Trulance |
Xepi |
|
benznidazole** |
Giapreza |
Mavyret |
Rhopressa |
Tymlos |
Zejula |
|
Bespons... Read More
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