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Search results for abiraterone root_names_stdName in Standardized Name (approximate match)
Status:
US Approved Rx
(2021)
Source:
NDA214916
(2021)
Source URL:
First approved in 2021
Source:
NDA214916
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Difelikefalin is an orally bioavailable second-generation peptide. It is an investigational peripheral kappa opioid receptor agonist. Difelikefalin significantly reduced moderate to severe chronic itching while achieving across-the-board clinically meaningful improvements in quality of life measures in patients with hemodialysis-associated pruritus in a phase 2 study. In a phase 2 clinical investigation, difelikefalin was safe, well tolerated and showed robust analgesic activity for postoperative pain in female patients undergoing laparoscopy, with a significant reduction in post-operative morphine consumption and opioid-related side effects. Now difelikefalin is in phase III clinical trials for the treatment of post-operative pain and pruritus.
Status:
US Approved Rx
(2020)
Source:
NDA213702
(2020)
Source URL:
First approved in 2020
Source:
NDA213702
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Lurbinectedin (PM-01183) - is a synthetic tetrahydropyrrolo [4, 3, 2-de]quinolin-8(1H)-one alkaloid analogue with potential antineoplastic activity. Lurbinectedin covalently binds to residues lying in the minor groove of DNA, which may result in delayed progression through S phase, cell cycle arrest in the G2/M phase and cell death. Lurbinectedin is a novel anticancer agent currently undergoing late-stage (Phase II /III) clinical evaluation in platinum-resistant ovarian, BRCA1/2-mutated breast and small-cell lung cancer. Lurbinectedin is structurally related to trabectedin and it inhibits active transcription and the DNA repair machinery in tumour cells.
Status:
US Approved Rx
(2018)
Source:
NDA210910
(2018)
Source URL:
First approved in 2018
Source:
NDA210910
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Rifamycin SV is a derivative of antibiotic rifamycin B (the natural fermentation product of S. mediterranei broths). The primary target of rifampicin on whole bacteria is the synthesis of RNA. Rifamycin belongs to the ansamycin class of antibacterial drugs and acts by inhibiting the beta subunit of the bacterial DNA-dependent RNA polymerase, blocking one of the steps in DNA transcription. This results in inhibition of bacterial synthesis and consequently growth of bacteria. Rifampicin exhibits bactericidal activity on Gram-positive and Gram-negative bacteria and on mycobacteria. Rifamycin SV MMX® (AEMCOLO), a non-absorbable rifamycin antibiotic formulated using the multi-matrix system, was designed to exhibit its pharmacological action on the distal small intestine and colon. AEMCOLO is indicated for the treatment of travelers’ diarrhea (TD) caused by non-invasive strains of Escherichia coli in adults.
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
(2023)
Source:
NDA216793
(2023)
Source URL:
First approved in 2011
Source:
NDA202379
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Abiraterone acetate (trade name Zytiga) is a prodrug to the abiraterone, steroidal compound with antiandrogen activity and a 17 α-hydroxylase/C17,20-lyase (CYP17) inhibitor. It is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone acetate is converted in vivo to abiraterone which inhibits CYP17, enzyme expressed in testicular, adrenal, and prostatic tumor tissues and required for androgen biosynthesis. Administration of this agent may suppress testosterone production by both the testes and the adrenals to castrate-range levels. Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies, such as treatment with GnRH agonists or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumor.
Status:
US Approved Rx
(2010)
Source:
NDA022474
(2010)
Source URL:
First approved in 2010
Source:
NDA022474
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Ulipristal acetate (also known as CDB-2914 and PGL4001 and trade name Ella in the U.S) is a novel oral emergency contraceptive designed and developed by HRA Pharma. It is a selective progesterone receptor modulator, which reversibly blocks the progesterone receptors in target tissues it was approved in May 2009 by the European Commission and in August 2010 by the FDA as safe and effective in preventing unintended pregnancy for up to 120 hours – or five days – post- unprotected intercourse or contraceptive failure. Ella is not intended for routine use as a contraceptive. When taken immediately before ovulation is to occur, ella postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy. The most common side effects are: headache, nausea, stomach (abdominal) pain, menstrual pain. Some women taking ella may have their next period earlier or later than expected. If your period is more than a week late, you should get a pregnancy test.
Status:
US Approved Rx
(2021)
Source:
NDA207949
(2021)
Source URL:
First approved in 2010
Source:
NDA201023
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Cabazitaxel (JEVTANA®) is an antineoplastic agent belonging to the taxane class and is used to treat people with prostate cancer that has progressed despite treatment with docetaxel. It is prepared by semi-synthesis with a precursor extracted from yew needles (10-deacetylbaccatin III). Cabazitaxel (JEVTANA®) is a microtubule inhibitor. It binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell.
Status:
US Approved Rx
(2009)
Source:
NDA022307
(2009)
Source URL:
First approved in 2009
Source:
NDA022307
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Prasugrel, a thienopyridine derivative, is a platelet activation and aggregation inhibitor structurally and pharmacologically related to clopidogrel and ticlopidine. Similar to clopidogrel, prasugrel is a prodrug that requires enzymatic transformation in the liver to its active metabolite, R-138727. R-138727 irreversibly binds to P2Y12 type ADP receptors on platelets thus preventing activation of the GPIIb/IIIa receptor complex. As a result, inhibition of ADP-mediated platelet activation and aggregation occurs. Prasugrel was developed by Daiichi Sankyo Co. and is currently marketed under the brand name EFFIENT in the United States and Canada in cooperation with Eli Lilly and Company for acute coronary syndromes planned for percutaneous coronary intervention (PCI). FDA approved in 2009.
Status:
US Approved Rx
(2008)
Source:
NDA022201
(2008)
Source URL:
First approved in 2008
Source:
NDA022201
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
DEGARELIX (FIRMAGON®) is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. It is a GnRH receptor antagonist. It binds reversibly to the pituitary GnRH receptors, thereby reducing the release of gonadotropins and consequently testosterone. DEGARELIX (FIRMAGON®) is effective in achieving and maintaining testosterone suppression below the castration level of 50 ng/dL and is indicated for the treatment of patients with advanced prostate cancer.
Status:
US Approved Rx
(2021)
Source:
ANDA211776
(2021)
Source URL:
First approved in 2008
Source:
NDA022212
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Difluprednate is a corticosteroid used as an anti-inflammatory steroidal drug used primarily in ocular surgery. It is thought to act by the induction of phospholipase A2 inhibitory proteins (lipocortins). It is postulated that these proteins control the biosynthesis of potent mediators of infammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. It is marketed by Alcon under the tradename Durezol.