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.
View animated charts from the 2013 Novel New Drugs Summary publication on the right. (Not viewable in Internet Explorer version 7 and below.)
2013 Novel New Drugs Summary (PDF - 3MB)
The list below includes the NMEs and BLAs approved by CDER in calendar year 2014.
(The Drug Name link provides full product details, i.e., prescribing information, approval history, and reviews.)
What It’s Used For
|27.||Keytruda||pembrolizumab||9/4/2014||For treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.|
|26.||Cerdelga||eliglustat||8/19/2014||For the long-term treatment of adult patients with the Type 1 form of Gaucher disease|
|25.||Plegridy||peginterferon beta-1a||8/15/2014||For the treatment of patients with relapsing forms of multiple sclerosis|
|24.||Belsomra||suvorexant||8/13/2014||To treat difficulty in falling and staying asleep (insomnia)|
|23.||Orbactiv||oritavancin||8/6/2014||To treat adults with skin infections|
|22.||Jardiance||empagliflozin||8/1/2104||To improve gylcemic control in adults with type 2 diabetes|
|21.||olodaterol||7/31/2014||To treat chronic obstructive pulmonary disease|
|20. ||Zydelig||idelalisib||7/23/2014||To treat patients with trhee types of blood cancers|
|19.||Kerydin||tavaborole||7/7/2014||For the topical treatment of onychomycosis of the toenails |
(No Press Release)
|18.||Beleodaq||belinostat||7/3/2014||To treat patients with peripheral T-cell lymphoma (PTCL) |
|17.||tedizolid phosphate||6/20/2014||To treat adults with skin infections|
Treat mild to moderate onychomycosis (fungal infection)
No Press Release
|15.||Dalvance||dalbavancin||5/23/2014||To treat adults with skin infections|
|14.||Entyvio||vedolizumab||5/20/2014||To treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease|
|13.||vorapaxar||5/8/2014||To reduce the risk of heart attacks and stroke in high-risk patients|
|12.||ceritinib||4/29/2014||To treat patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC)|
|11.||siltuximab||4/23/2014||To treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes)|
|10.||ramucirumab||4/21/2014||To treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma|
|9.||albiglutide||4/15/2014||To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes|
|8.||apremilast||3/21/2014||To treat adults with active psoriatic arthritis (PsA)|
|7.||miltefosine||3/19/2014||To treat a tropical disease called leishmaniasis|
|6.||florbetaben F 18 injection||3/19/2014|
For Positron EmissionTomography (PET) imaging of the brain
|5.||metreleptin for injection||2/24/2014||To treat the complications of leptin deficiency|
|4.||droxidopa||2/18/2014||To treat neurogenic orthostatic hypotension (NOH)|
Treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome)
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.
|1.||Farxiga||dapaglifozin||1/8/2014||To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes|