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Restrict the search for
fludrocortisone acetate
to a specific field?
Status:
US Previously Marketed
Source:
GEREF by EMD SERONO
(1990)
Source URL:
First approved in 1990
Source:
GEREF by EMD SERONO
Source URL:
Class:
PROTEIN
Conditions:
Sermorelin, a 29 amino acid analog of human growth hormone-releasing hormone (GHRH), is the shortest synthetic peptide with a full biological activity of GHRH which is used as a diagnostic agent to assess growth hormone (GH) secretion for the purpose of diagnosing growth hormone deficiency. Intravenous and subcutaneous sermorelin specifically stimulate growth hormone secretion from the anterior pituitary. Sermorelin binds to the growth hormone releasing hormone receptor and mimics native GRF in its ability to stimulate growth hormone secretion. Hormone responses to intravenous sermorelin appear to be a rapid and relatively specific test for the diagnosis of growth hormone deficiency.
Status:
US Previously Marketed
Source:
LUTREPULSE KIT by FERRING
(1989)
Source URL:
First approved in 1978
Source:
NADA098379
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Gonadorelin is a synthetic decapeptide prepared using solid phase peptide synthesis. GnRH is responsible for the release of follicle stimulating hormone and leutinizing hormone from the anterior pitutitary. In the pituitary GnRH stimulates synthesis and release of FSH and LH, a process that is controlled by the frequency and amplitude of GnRH pulses, as well as the feedback of androgens and estrogens. The pulsatility of GnRH secretion has been seen in all vertebrates, and it is necessary to ensure a correct reproductive function. Thus a single hormone, GnRH, controls a complex process of follicular growth, ovulation, and corpus luteum maintenance in the female, and spermatogenesis in the male. Its short half life requires infusion pumps for its clinical use. Gonadorelin is used for the treatment of amenorrhea, delayed puberty, and infertility the administration of gonadorelin is used to simulate the physiologic release of GnRH from the hypothalamus in treatment of delayed puberty, treatment of infertility caused by hypogonadotropic hypogonadism, and induction of ovulation in those women with hypothalamic amenorrhea. This results in increased levels of pituitary gonadotropins LH and FSH, which subsequently stimulate the gonads to produce reproductive steroids.
Status:
US Previously Marketed
First approved in 1978
Class:
PROTEIN
Seractide is a polypeptide hormone corresponding to thirty-nine amino acids of human corticotropin that differs from full-length human corticotropin at four positions. Seractide is potent endogenous melanocortin receptor 2 (MC ) agonist. Seractide stimulates the cortex of the adrenal gland and boosts the synthesis of corticosteroids, mainly glucocorticoids but also sex steroids (androgens). Seractide, was approved by FDA in 1978, but was never marketed. The Seractide, that was ultimately withdrawn by FDA in 2014 for safety reasons.
Status:
Possibly Marketed Outside US
Source:
NCT04677712: Phase 4 Interventional Completed Edematous Fibrosclerotic Panniculopathy (EFP)
(2020)
Source URL:
First approved in 2000
Source:
M016
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT02333591: Phase 4 Interventional Completed Coronary Microvascular Dysfunction
(2016)
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT00613964: Phase 4 Interventional Terminated Heart Failure
(2009)
Source URL:
Class:
PROTEIN
Carperitide is a synthetic, recombinant atrial natriuretic peptide with both vasodilating and diuretic activity that was developed by Asubio Pharma and used in Japan for acute heart failure treatment. Although the current Japanese Society of Cardiology guidelines for treatment of acute heart failure (AHF) make a class IIa recommendation for Carperitide, a recent meta-analysis and retrospective study revealed that Carperitide could not improve survival rates and was rather associated with a more than double in-hospital mortality rate in patients with AHF.
Status:
Possibly Marketed Outside US
Source:
NCT00720902: Phase 4 Interventional Terminated Growth Hormone Deficiency
(2007)
Source URL:
Class:
PROTEIN
Somatorelin is 29 amino acid analogue of human growth hormone-releasing hormone used as a diagnostic agent for determining growth hormone deficiency. Growth-hormone-releasing hormone (GHRH, somatoliberin) is the hypothalamic peptide hormone that specifically stimulates synthesis and release of growth hormone (GH, somatotropin) by somatotrope cells of the anterior pituitary gland. The hypothalamic hormone growth hormone (GH)-releasing hormone (GHRH) acts on specific GHRH receptors (GHRH-R) in the anterior pituitary gland to stimulate the synthesis and secretion of GH and to promote somatotrope expansion. Somatorelin is applied to determine the somatotropic function of the anterior pituitary gland in cases of suspected growth hormone deficiency. The test distinguishes between pituitary and hypothalamic disorders but is not suitable as a screening test for growth hormone deficiencies. Somatorelin has been used in trials studying the treatment of Aging, Elderly, Sleep Disorders, Hormone Deficiency, and Mild Cognitive Impairment.
Status:
US Approved Rx
(2000)
First approved in 1994
Source:
BLA103936
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved OTC
Source:
21 CFR 349.12(d)(4) ophthalmic:demulcents polysorbate 80
Source URL:
First approved in 1949
Class:
POLYMER
Conditions:
Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the manufacture of the popular antiarrhythmic amiodarone. Polysorbate 80 is also used as an excipient in some European and Canadian influenza vaccines. Influenza vaccines contain 25 μg of polysorbate 80 per dose. Polysorbate 80 is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb. In Europe and America, people eat about 100 mg of polysorbate 80 in foods per day on average. Polysorbate 80 has not been found to be carcinogenic. Rats fed with diets containing up to 5% polysorbate 80 by volume for 12 weeks showed no toxic effects.
