This post “33 Novel Drug Approvals for 2019: Uses & Info” seeks to provide info on a large number of new, novel drugs being approved by the Food and Drug Administration (FDA). What’s a novel drug? 

Each year, the FDA’s Center for Drug Evaluation and Research (CDER) approves hundreds of new medications, most of which are variations of previously existing products, such as important new dosage forms of already-approved products, or cost-saving generic formulations. These new products contribute to the quality of care, greater access to medication, more consumer choice, and a competitive marketplace that enhances affordability and public health. However, products in a small subset of these new approvals, which we refer to as novel drugs, are among the more truly innovative products that often help advance clinical care to another level. This Oct. 24, 2019 press release¹  from the FDA gives an update on the newest novel drugs.

Innovation drives progress.

When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With 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, FDA provides scientific and regulatory advice needed to bring new therapies to the market.

The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.

Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.

What are New Molecular Entities

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by the FDA previously, 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 contain active moieties that are closely related to active moieties in products that have previously been approved by the FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from the 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.

Click on Drug Name for more information

Jay Harold hopes you enjoyed this post, “33 Novel Drug Approvals for 2019: Uses & Info” seeks to provide helpful information about new drugs. Please Share it and read more about Jay Harold here.  Please take this advice from  Muhammad Ali and give back to others. “Service to others is the rent you pay for your room here on earth.”

Bibliography

1. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019