{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
Status:
US Approved Rx
(2020)
Source:
ANDA208202
(2020)
Source URL:
First approved in 2011
Source:
NDA022567
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Vilazodone is a serotonergic antidepressant. The mechanism of the antidepressant effect of vilazodone is not fully understood but is thought to be related to its inhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown. The side effects include activation of mania/hypomania in patients with bipolar disorder, seizures can occur with treatment in patients with a seizure disorder.
Status:
US Approved Rx
(2012)
Source:
NDA203993
(2012)
Source URL:
First approved in 2011
Source:
NDA202067
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Clobazam belongs to the 1,5-benzodiazepine class of drugs with antiepileptic properties. It has been used to treat anxiety and epilepsy since 1970s. In the US clobazam was approved for marketing in October of 2011 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. It is also approved for adjunctive therapy for epilepsy in patients who have not responded to first-line drugs and in children who are refractory to first-line drugs. The mechanism of action for clobazam is not fully understood but is thought to involve what is known as potentiation of GABAergic neurotransmission resulting from binding at a benzodiazepine site at the GABA(A) receptor. Possible side effects: constipation, fever, drowsiness, sedation, ataxia, aggressive behavior, lethargy, drooling, and irritability. Other side effects include: urinary tract infection, pneumonia, cough, dysphagia, dysarthria, bronchitis, insomnia, fatigue, decreased appetite, and increased appetite.
Status:
US Approved Rx
(2017)
Source:
ANDA202349
(2017)
Source URL:
First approved in 2010
Source:
NDA022252
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Dienogest (Natazia) is a hybrid progestogen that combines properties of both the 19-nortestosterone derivatives and the progesterone derivatives. It is indicated for use by women to prevent pregnancy and for the treatment of heavy menstrual bleeding in women without organic pathology. Dienogest is also approved in Europe, Australia, Malaysia, Singapore and Japan for the treatment of endometriosis. It is lowers the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. Dienogest exhibits highly selective binding to the progesterone receptor. It has high progestational and significant antiandrogenic activity, but only moderate antigonadotrophic activity. The most common adverse reactions in clinical trials for Natazia are headache (including migraines), breast pain, menstrual disorders, nausea or vomiting, acne, mood changes and increased weight.
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
(2010)
Source:
NDA201023
(2010)
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
(2024)
Source:
ANDA218047
(2024)
Source URL:
First approved in 2010
Source:
NDA201532
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
ERIBULIN MESYLATE (HALAVEN®) is a microtubule dynamics inhibitor. It is a synthetic analog of halichondrin B, a product isolated from the marine sponge Halichondria okadai. ERIBULIN MESYLATE (HALAVEN®) inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. It exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after the prolonged mitotic blockage. ERIBULIN MESYLATE (HALAVEN®) is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. It is also indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Status:
US Approved Rx
(2010)
Source:
NDA022134
(2010)
Source URL:
First approved in 2010
Source:
NDA022134
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Alcaftadine is a broad-spectrum antihistamine displaying a high affinity for histamine H1 and H2 receptors and a lower affinity for H4 receptors. It also exhibits modulatory action on immune cell recruitment and mast cell stabilizing effects. Alcaftadine is an inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been
demonstrated. LASTACAFT® (alcaftadine ophthalmic solution) indicated for the prevention of itching associated with allergic conjunctivitis.
Status:
US Approved Rx
(2010)
Source:
NDA200327
(2010)
Source URL:
First approved in 2010
Source:
NDA200327
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ceftaroline is a fifth-generation broad-spectrum cephalosporin with potent antimicrobial activity against Gram-positive and Gram-negative pathogens. Ceftaroline is the bioactive metabolite of ceftaroline fosamil, an N-phosphonoamino water-soluble cephalosporin prodrug, which is rapidly converted in vivo upon the hydrolysis of the phosphonate group by plasma phosphatises. Ceftaroline fosamil is being developed by Forest Laboratories, under a license from Takeda. In 2010, the U.S. Food and Drug Administration (FDA) approved ceftaroline fosamil for use in the treatment of acute bacterial skin and skin structure infections as well as community-acquired pneumonia. Ceftaroline has bactericidal activity against methicillin-resistant Staphylococcus aureus, therefore serving as an attractive alternative agent for the treatment of methicillin-resistant Staphylococcus aureus bacteremia when approved agents are contraindicated or treatment failures have occurred. Like other β-lactams, ceftaroline’s mechanism of action is mediated by binding to the penicillin-binding protein (PBP), the enzyme mediating the cross-linking transpeptidation of the peptidoglycan which are the terminal steps in completing formation of the bacterial cell wall. MRSA strains have a mutated PBP2a which prohibits β-lactam antibiotics from accessing its active site that mediates the transpeptidation reaction. Ceftaroline possesses an ethoxyimino side-chain mimicking a portion of a cell wall structure, which acts as a “Trojan horse”, allosterically opening and facilitating access to the active site of the PBP2a. Based on clinical trial data to date, ceftaroline appears to be safe and well-tolerated. Since ceftaroline is a cephalosporin, it has caused serious hypersensitivity reactions in patients who are allergic to cephalosporins and among some patients with penicillin allergies.
Status:
US Approved Rx
(2021)
Source:
NDA214358
(2021)
Source URL:
First approved in 2010
Source:
NDA022512
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Dabigatran (Pradaxa, Prazaxa) is an anticoagulant medication that can be taken by mouth. FDA approved on October 19, 2010. Dabigatran directly inhibits thrombin in a concentration-dependent, reversible, specific, and competitive manner which results in a prolongation of aPTT (partial thromboplastin time), ECT (Ecarin clotting time), and TT (thrombin time). It may increase INR but this laboratory parameter is relatively insensitive to the activity of dabigatran. Dabigatran is indicated for the prevention of venous thromboembolic events in patients who have undergone elective hip or knee replacement surgery (based on RE-NOVATE, RE-MODEL, and RE-MOBILIZE trials). In 2010, it was approved in the US and Canada for prevention of stroke and systemic embolism in patients with atrial fibrillation (approval based on the RE-LY trial). Contraindications: severe renal impairment (CrCL < 30 ml/min); haemorrhagic manifestations, bleeding diathesis or spontaneous or pharmacologic impairment of haemostasis; lesions at risk of clinically significant bleeding (e.g. extensive cerebral infarction (haemorrhagic or ischemic) in the last 6 months, active peptic ulcer disease); concomitant treatment with P-glycoprotein inhibitors (e.g. oral ketoconazole, verapamil); and those with known hypersensitivity to dabigatran, dabigatran etexilate or any ingredient used in the formulation or component of the container. As of December 2012, dabigatran is contraindicated in patients with mechanical prosthetic heart valves.
Status:
US Approved Rx
(2021)
Source:
ANDA208047
(2021)
Source URL:
First approved in 2010
Source:
NDA200603
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Lurasidone is a novel antipsychotic agent approved for the treatment of schizophrenia in a number of countries including the UK and is also approved in the USA and Canada for the treatment of bipolar depression as either a monotherapy or adjunctive therapy with lithium or valproate. In addition, lurasidone is in phase III of a clinical trial for the treatment patient with major depressive disorder and for the treatment of irritability associated with autistic disorder. The mechanism of action of lurasidone, as with other drugs having efficacy in schizophrenia, is unknown but is known, that lurasidone has a high affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors.