Tahun 2013 lalu FDA merilis OAD baru setipe dg pioglitazone :
New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products of 2014
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 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.
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 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 nonetheless contain active
moieties that are closely related to active moieties in products that
have previously been approved by 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 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.
The list below includes the NMEs approved by CDER in calendar year 2014.
(The Drug Name link provides full product details, i.e., prescribing information, approval history, and reviews.)
|
2013 Novel New Drugs Summary (PDF - 3MB)
|
| No. |
Drug Name
|
Active Ingredient
|
Date
|
What it’s used for
|
|---|---|---|---|---|
| 2. | Hetlioz | tasimelteon | 1/31/2014 | To
treat non-24- hour sleep-wake disorder (“non-24”) in totally blind
individuals. Non-24 is a chronic circadian rhythm (body clock) disorder
in the blind that causes problems with the timing of sleep. Press Release |
| 1. | Farxiga | dapaglifozin | 1/8/2014 | To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Press Release |
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