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
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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