{{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
(2007)
Source:
NDA022042
(2007)
Source URL:
First approved in 1997
Source:
NDA020815
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Raloxifene (marketed as Evista by Eli Lilly and Company) is an oral selective estrogen receptor modulator (SERM) that has estrogenic actions on bone and anti-estrogenic actions on the uterus and breast. Raloxifene binds to estrogen receptors, resulting in differential expression of multiple estrogen-regulated genes in different tissues. Raloxifene produces estrogen-like effects on bone, reducing resorption of bone and increasing bone mineral density in postmenopausal women, thus slowing the rate of bone loss. The maintenance of bone mass by raloxifene and estrogens is, in part, through the regulation of the gene-encoding transforming growth factor-β3 (TGF-β3), which is a bone matrix protein with antiosteoclastic properties. Raloxifene activates TGF-β3 through pathways that are estrogen receptor-mediated but involve DNA sequences distinct from the estrogen response element. The drug also binds to the estrogen receptor and acts as an estrogen agonist in preosteoclastic cells, which results in the inhibition of their proliferative capacity. This inhibition is thought to contribute to the drug's effect on bone resorption. Other mechanisms include the suppression of the activity of the bone-resorbing cytokine interleukin-6 promoter activity. Raloxifene also antagonizes the effects of estrogen on mammary tissue and blocks uterotrophic responses to estrogen. By competing with estrogens for the estrogen receptors in reproductive tissue, raloxifene prevents the transcriptional activation of genes containing the estrogen response element. As well, raloxifene inhibits the estradiol-dependent proliferation of MCF-7 human mammary tumor cells in vitro. The mechanism of action of raloxifene has not been fully determined, but evidence suggests that the drug's tissue-specific estrogen agonist or antagonist activity is related to the structural differences between the raloxifene-estrogen receptor complex (specifically the surface topography of AF-2) and the estrogen-estrogen receptor complex. Also, the existence of at least 2 estrogen receptors (ERα, ERβ) may contribute to the tissue specificity of raloxifene. Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. It is also used for reduction of risk and treatment of invasive breast cancer, and it also reduces breast density. For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. Common adverse events considered to be drug-related were hot flashes and leg cramps.
Status:
US Approved Rx
(2012)
Source:
ANDA202200
(2012)
Source URL:
First approved in 1996
Source:
LEVAQUIN by JANSSEN PHARMS
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. Levofloxacin is used for oral and intravenous administration. Levofloxacin is sold under brand name levaquin and is used to treat infections in adults (≥18 years of age) caused by designated, susceptible bacteria such as, pneumonia: nosocomial and community acquired; skin and skin structure infections: complicated and uncomplicated; chronic bacterial prostatitis; inhalational anthrax. In addition this drug is used to treat plague; urinary tract infections: complicated and uncomplicated; acute pyelonephritis; acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Levofloxacin, like other fluoroquinolones, inhibits the bacterial DNA gyrase, halting DNA replication. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing. In addition, levofloxacin inhibits a bacterial type II topoisomerase.
Status:
US Approved Rx
(2012)
Source:
ANDA202200
(2012)
Source URL:
First approved in 1996
Source:
LEVAQUIN by JANSSEN PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. Levofloxacin is used for oral and intravenous administration. Levofloxacin is sold under brand name levaquin and is used to treat infections in adults (≥18 years of age) caused by designated, susceptible bacteria such as, pneumonia: nosocomial and community acquired; skin and skin structure infections: complicated and uncomplicated; chronic bacterial prostatitis; inhalational anthrax. In addition this drug is used to treat plague; urinary tract infections: complicated and uncomplicated; acute pyelonephritis; acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Levofloxacin, like other fluoroquinolones, inhibits the bacterial DNA gyrase, halting DNA replication. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing. In addition, levofloxacin inhibits a bacterial type II topoisomerase.
Status:
US Approved Rx
(2012)
Source:
ANDA202200
(2012)
Source URL:
First approved in 1996
Source:
LEVAQUIN by JANSSEN PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. Levofloxacin is used for oral and intravenous administration. Levofloxacin is sold under brand name levaquin and is used to treat infections in adults (≥18 years of age) caused by designated, susceptible bacteria such as, pneumonia: nosocomial and community acquired; skin and skin structure infections: complicated and uncomplicated; chronic bacterial prostatitis; inhalational anthrax. In addition this drug is used to treat plague; urinary tract infections: complicated and uncomplicated; acute pyelonephritis; acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Levofloxacin, like other fluoroquinolones, inhibits the bacterial DNA gyrase, halting DNA replication. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing. In addition, levofloxacin inhibits a bacterial type II topoisomerase.
Status:
US Approved Rx
(2012)
Source:
ANDA202200
(2012)
Source URL:
First approved in 1996
Source:
LEVAQUIN by JANSSEN PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. Levofloxacin is used for oral and intravenous administration. Levofloxacin is sold under brand name levaquin and is used to treat infections in adults (≥18 years of age) caused by designated, susceptible bacteria such as, pneumonia: nosocomial and community acquired; skin and skin structure infections: complicated and uncomplicated; chronic bacterial prostatitis; inhalational anthrax. In addition this drug is used to treat plague; urinary tract infections: complicated and uncomplicated; acute pyelonephritis; acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Levofloxacin, like other fluoroquinolones, inhibits the bacterial DNA gyrase, halting DNA replication. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing. In addition, levofloxacin inhibits a bacterial type II topoisomerase.
Status:
US Approved Rx
(2012)
Source:
ANDA202200
(2012)
Source URL:
First approved in 1996
Source:
LEVAQUIN by JANSSEN PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. Levofloxacin is used for oral and intravenous administration. Levofloxacin is sold under brand name levaquin and is used to treat infections in adults (≥18 years of age) caused by designated, susceptible bacteria such as, pneumonia: nosocomial and community acquired; skin and skin structure infections: complicated and uncomplicated; chronic bacterial prostatitis; inhalational anthrax. In addition this drug is used to treat plague; urinary tract infections: complicated and uncomplicated; acute pyelonephritis; acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Levofloxacin, like other fluoroquinolones, inhibits the bacterial DNA gyrase, halting DNA replication. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing. In addition, levofloxacin inhibits a bacterial type II topoisomerase.
Status:
US Approved Rx
(2010)
Source:
ANDA091629
(2010)
Source URL:
First approved in 1995
Source:
NDA020386
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Losartan is a selective, competitive angiotensin II receptor type 1 (AT1) antagonist. Losartant is recommended as one of several preferred agents for the initial management of hypertension. Administration of losartan reduces the risk of stroke in patients with hypertension and left ventricular hypertrophy. Losartan is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.
Status:
US Approved Rx
(2024)
Source:
NDA216482
(2024)
Source URL:
First approved in 1995
Source:
NDA050722
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Mycophenolic acid (MPA) possesses antibacterial, antifungal, antiviral, immunosuppressive and anticancer properties. Mycophenolic acid (MPA) is a fungal metabolite that was initially discovered by Bartolomeo Gosio in 1893 as an antibiotic against anthrax bacillus, Bacillus anthracis. It is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. It was approved under the brand name Myfortic for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. Myfortic is to be used in combination with cyclosporine and corticosteroids.
Status:
US Approved Rx
(2022)
Source:
ANDA212955
(2022)
Source URL:
First approved in 1995
Source:
REVEX by HIKMA
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Nalmefene is the first medication approved for alcoholism
with the primary goal of reducing alcohol intake in an as
needed approach. Nalmefene
received a marketing authorization valid throughout the
European Union on February 25, 2013 and is under development
in Asia. Nalmefene is an opioid system modulator with a
distinct μ, δ, and κ receptor profile. In vitro studies have demonstrated
that Nalmefene is a selective opioid receptor ligand
with antagonist activity at the μ and δ receptors and partial
agonist activity at the κ receptor. In vivo studies have demonstrated
that nalmefene reduces alcohol consumption, possibly
by modulating cortico-mesolimbic functions. In the US, immediate-release injectable nalmefene was approved in 1995 as an antidote for opioid overdose. It was sold under the trade name Revex. The product was discontinued by its manufacturer around 2008. Currently Nalmefene is sold under the trade name Selincro. Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level, without physical withdrawal symptoms and who do not require immediate detoxification.
Status:
US Approved Rx
(2009)
Source:
ANDA079089
(2009)
Source URL:
First approved in 1995
Source:
NDA020498
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Bicalutamide (brand name Casodex) is an oral non-steroidal anti-androgen for prostate cancer. It is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. Bicalutamide competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen. When CASODEX is combined with luteinizing hormone releasing hormone (LHRH) analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown. Bicalutamide undergoes stereospecific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation. Both the parent and metabolite glucuronides are eliminated in the urine and feces. The S-enantiomer is rapidly cleared relative to the R-enantiomer, with the R-enantiomer accounting for about 99% of total steady-state plasma levels.