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1 Jan 2017

Key finding from USFDA’s new drug approval in the year 2016

  • Total 22 New Molecule approved in the year 2016.
  • New Molecule includes drugs and biopharmaceuticals.
  • 7 new monoclonal antibody are approved in the year. So, out of Out of 22 new drugs 7 Monoclonal antibody (MAB) are present.
  • 2016 has lowest number of new drug approval from 2011.
  • Out of 22 new molecule, 7 new molecules are orphan drug
  • Out of 22 new molecule, 4 molecule received fast track designation 
  • Out of 22 new molecule, 9 molecules approved under priority review 
  • Out of 22 new molecule, 5 molecules got accelerated approval 
  • Out of 22 new molecule, 6 molecules got breakthrough therapy designation 

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Breakthrough Therapy
A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.

Accelerated Approval
These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.

Priority Review
A Priority Review designation means FDA’s goal is to take action on an application within 6 months.

USFDA New Drugs Approved over the years 

Year Number of New Molecule Approved
2016 22
2015 45
2014 41
2013 27
2012 39
2011 29

List of New Molecular Approval in 2016

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

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