miércoles, 4 de enero de 2017

Drug Innovation > Novel Drug Approvals for 2016

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Novel Drug Approvals for 2016

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.

No.	Drug Name	Active Ingredient	Approval Date	FDA-approved use on approval date
22.	Spinraza	nusinersen	12/23/2016	To treat children and adults with spinal muscular atrophy (SMA) Press Release
21.	Rubraca	rucaparib	12/19/2016	To treat women with a certain type of ovarian cancer Press Release Drug Trials Snapshot
20.	Eucrisa	crisaborole	12/14/2016	To treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older Press Release Drug Trials Snapshot
19.	Zinplava	bezlotoxumab	10/21/2016	To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older Drug Trials Snapshot
18.	Lartruvo	olaratumab	10/19/2016	To treat adults with certain types of soft tissue sarcoma Press Release Drug Trials Snapshot
17.	Exondys 51	eteplirsen	9/19/2016	To treat patients with Duchenne muscular dystrophy Press Release Drug Trials Snapshot
16.	Adlyxin	lixisenatide	7/27/2016	To improve glycemic control (blood sugar levels) Press Release Drug Trials Snapshot
15.	Xiidra	lifitegrast ophthalmic solution	7/11/2016	To treat the signs and symptoms of dry eye disease Press Release Drug Trials Snapshot
14.	Epclusa	sofosbuvir and velpatasvir	6/28/2016	To treat all six major forms of hepatitis C virus Press Release Drug Trials Snapshot
13.	NETSPOT	gallium Ga 68 dotatate	6/1/2016	A diagnostic imaging agent to detect rare neuroendocrine tumors Press Release Drug Trials Snapshot
12.	Axumin	fluciclovine F 18	5/27/2016	A new diagnostic imaging agent to detect recurrent prostate cancer Press release Drug Trials Snapshot
11.	Ocaliva	obeticholic acid	5/27/2016	To treat rare, chronic liver disease Press release Drug Trials Snapshot
10.	Zinbryta	daclizumab	5/27/2016	To treat multiple sclerosis Press Release Drug Trials Snapshot
9.	Tecentriq	atezolizumab	5/18/2016	To treat urothelial carcinoma, the most common type of bladder cancer Press Release Drug Trials Snapshot
8.	Nuplazid	pimavanserin	4/29/2016	To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease Press Release Drug Trials Snapshot
7.	Venclexta	venetoclax	4/11/2016	For chronic lymphocytic leukemia in patients with a specific chromosomal abnormality Press Release Drug Trials Snapshot
6.	Defitelio	defibrotide sodium	3/30/3016	To treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation Press Release Drug Trials Snapshot
5.	Cinqair	reslizumab	3/23/2016	To treat severe asthma Press Release Drug Trials Snapshot
4.	Taltz	ixekizumab	3/22/2016	To treat adults with moderate-to-severe plaque psoriasis. Press Release Drug Trials Snapshot
3.	Anthim	obiltoxaximab	3/18/2016	To treat inhalational anthrax in combination with appropriate antibacterial drugs. Press Release Drug Trials Snapshot
2.	Briviact	brivaracetam	2/18/2016	To treat partial onset seizures in patients age 16 years and older with epilepsy. Press Release Drug Trials Snapshot
1.	Zepatier	elbasvir and grazoprevir	1/28/2016	To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Press Release Drug Trials Snapshot

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA). For instance, new information may become available which could lead to a reconsideration of the original designation or status. If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.