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        Development & Approval Process | Drugs

New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

                        
                Novel Drug Approvals for 2024
          Novel Drug Approvals for 2023
          Novel Drug Approvals for 2022
          Novel Drug Approvals for 2021
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          Development & Approval Process | Drugs
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological ProductsDevelopment & Approval Process | Drugs New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  	
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    PrintNew Drug Therapy Approvals 2022
Advancing Health Through Innovation: New Drug Therapy Approvals 2022 (PDF - 6.8 KB)Text version

Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive assessment. To do so, CDER relies on its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat.

Each year, CDER approves a wide range of new drugs and biological products:

Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2022. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2022.
	Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that FDA has previously approved. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.




**2014-2011 Reports are in the**FDA Archive



New Molecular Entity and New Therapeutic Biological Product Approvals (CDER only)

Novel Drug Approvals for 2021
	Novel Drug Approvals for 2020
	Novel Drug Approvals for 2019
	Novel Drug Approvals for 2018
	Novel Drug Approvals for 2017
	Novel Drug Approvals for 2016
	Novel Drug Approvals for 2015Drug Approval Information (CDER only)

Recent New and Generic Drug Approvals
	Drug Approval Reports by Month
	Drug and Biologic Approval and IND Activity ReportsRelated Information from Other FDA Centers

Innovation at FDA
	Innovation and Regulatory Science (CBER)Resources For You

Prescribing Information Resources
	Frequently Asked Questions: Breakthrough Therapies
	Critical Path Innovation Meetings (CPIM)
	CPIM FAQ's
		CPIM Topics Held to Date

                                                                                  Content current as of:
      05/22/2023
                  
                   
Regulated Product(s)
		 DrugsNew Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products                
                          

                        Novel Drug Approvals for 2024
          Novel Drug Approvals for 2023
          Novel Drug Approvals for 2022
          Novel Drug Approvals for 2021
          Novel Drug Approvals for 2020
          Novel Drug Approvals for 2019
          Novel Drug Approvals for 2018
          Novel Drug Approvals for 2017
          Novel Drug Approvals for 2016
          Novel Drug Approvals for 2015
 
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