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Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2016)
Source URL:
First approved in 2016
Source:
505G(a)(3)
Source URL:
Class:
CONCEPT
Status:
US Approved Rx
(2016)
Source:
NDA208573
(2016)
Source URL:
First approved in 2016
Source:
NDA208573
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Venetoclax (trade name Venclexta, also known as ABT-199) is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an antiapoptotic protein. BCL-2 and its related proteins BCL-XL and MCL-1 bind to and sequester pro-apoptotic signals in the cell, causing a down-regulation of apoptosis. As an oncogene and an important regulator of apoptosis, BCL-2 overexpression therefore results in increased tumor cell survival and resistance to chemotherapy. FDA approved Venetoclax in April 2016 for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. Also this drug in phase 3 clinical trial in combination therapy for the treatment patients with refractory myeloma and Acute Myeloid Leukemia. Common side effects include neutropenia, nausea, anemia, diarrhea, upper respiratory tract infection. Major side effects include tumor lysis syndrome and severe neutropenia.
Status:
US Approved Rx
(2020)
Source:
NDA213227
(2020)
Source URL:
First approved in 2016
Source:
NDA208547
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Dotatate, also known as DOTA-0-Tyr3-Octreotate, is a cyclic 8 amino acid peptide with a covalently bound chelator (dota). The peptide has the amino acid sequence: H-D-Phe-Cys-Tyr-D-Trp-Lys-ThrCys-Thr-OH, and contains one disulfide bond. After radiolabeling with Ga 68 (NETSPOT®) or with Lu 177 (LUTATHERA®), it is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Status:
US Approved Rx
(2016)
Source:
NDA209115
(2016)
Source URL:
First approved in 2016
Source:
NDA209115
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Rucaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of advanced mutant BRCA ovarian cancer. Rucaparib is being investigated in clinical trials against prostate cancer, breast cancer and other neoplasms.
Status:
US Approved Rx
(2016)
Source:
NDA208261
(2016)
Source URL:
First approved in 2016
Source:
NDA208261
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Grazoprevir is a second generation NS3/4A protease inhibitor approved in the EU and the USA for the treatment of hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients in combination with elbasvir (C virus (HCV) NS5A inhibitor) as the fixed-dose combination product Zepatier with or without ribavirin. In phase III trials, 12 or 16 weeks of treatment with once-daily elbasvir/grazoprevir (fixed-dose tablet or as individual agents), taken with or without ribavirin, generally provided high rates of sustained virological response at 12 weeks (SVR12) in treatment-naive and -experienced adult patients with chronic HCV genotype 1a, 1b or 4 infection, including those with or without compensated cirrhosis, HIV co-infection, inherited blood disorders or chronic kidney disease or patients receiving opioid agonist therapy or of Japanese origin. Elbasvir/grazoprevir was generally well tolerated. Thus, elbasvir/grazoprevir, with or without ribavirin, represents an effective new option for the treatment of adults with chronic HCV genotype 1 and 4 infection, including a number of difficult-to-treat populations.
Status:
US Approved Rx
(2016)
Source:
NDA208073
(2016)
Source URL:
First approved in 2016
Source:
NDA208073
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Lifitegrast (under brand name Xiidra) was approved as an ophthalmic solution for the treatment of the signs and symptoms of dry eye disease. Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1); a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). This LFA-1/ICAM-1 interaction is a key step in the inflammatory cascade that contributes to dry eye disease. Besides lifitegrast participates in phase II clinical trials for prevention of the signs and symptoms of allergic conjunctivitis.
Status:
US Approved Rx
(2016)
Source:
NDA209115
(2016)
Source URL:
First approved in 2016
Source:
NDA209115
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Rucaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of advanced mutant BRCA ovarian cancer. Rucaparib is being investigated in clinical trials against prostate cancer, breast cancer and other neoplasms.
Status:
US Approved Rx
(2016)
Source:
NDA207318
(2016)
Source URL:
First approved in 2016
Source:
NDA207318
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Pimavanserin, marketed under the trade name Nuplazid, a non-dopaminergic atypical antipsychotic developed by Acadia Pharmaceuticals is the first and only medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis is unknown. However, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors. In vitro, pimavanserin acts as an inverse agonist and antagonist at serotonin 5-HT2A receptors with high binding affinity (Ki value 0.087 nM) and at serotonin 5-HT2C receptors with lower binding affinity (Ki value 0.44 nM). Pimavanserin shows low binding to sigma 1 receptors (Ki value 120 nM) and has no appreciable affinity (Ki value >300 nM), to serotonin 5-HT2B, dopaminergic (including D2), muscarinic, histaminergic, or adrenergic receptors, or to calcium channels. Pimavanserin was approved by the FDA to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson's disease on April 29, 2016.
Status:
Possibly Marketed Outside US
Source:
XR CELLULAR MAGIC by MESO SYSTEM S.A.
(2016)
Source URL:
First approved in 2016
Source:
XR CELLULAR MAGIC by MESO SYSTEM S.A.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2016)
Source URL:
First approved in 2016
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)