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New therapeutic agents marketed in 1995
1Philadelphia College of Pharmacy and Science, USA.
Pennsylvania Medicine
|April 1, 1996
Summary
In 1995, the U.S. Food and Drug Administration (FDA) approved 28 new molecular entities (NMEs). A total of 23 therapeutic agents were newly marketed, with 12 approved NMEs becoming available in early 1996.
Area of Science:
- Pharmacology and Therapeutics
- Drug Development
- Regulatory Science
Background:
- The Food and Drug Administration (FDA) plays a crucial role in approving new drugs.
- Monitoring the introduction of new molecular entities (NMEs) to the market is essential for tracking therapeutic advancements.
Purpose of the Study:
- To review and analyze the new molecular entities (NMEs) approved by the FDA in 1995.
- To compare the properties of newly approved therapeutic agents with existing treatments.
Main Methods:
- Analysis of FDA approval data for 1995.
- Review of marketed therapeutic agents, including those approved in prior years.
- Comparative assessment of drug properties and therapeutic applications.
Main Results:
- The FDA approved 28 NMEs in 1995, with 26 for therapeutic use and 2 for diagnostics.
- Twenty-three therapeutic agents were newly marketed in the U.S. in 1995.
- Twelve therapeutic agents approved in 1995 were marketed in early 1996.
Conclusions:
- The year 1995 saw significant activity in new drug approvals and market introductions.
- This review provides a comparative overview of new therapeutic agents, aiding in understanding their place in the market.
- Further consultation of comprehensive references and product literature is recommended for detailed information.