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Restrict the search for
m nalidixic acid
to a specific field?
Status:
US Previously Marketed
Source:
OMONTYS PRESERVATIVE FREE by TAKEDA PHARMS USA
(2012)
Source URL:
First approved in 2012
Source:
OMONTYS PRESERVATIVE FREE by TAKEDA PHARMS USA
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Peginesatide (trade name Omontys, formerly Hematide), developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin. It was approved by the U.S. Food and Drug Administration for treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. Peginesatide is a synthetic peptide, attached to polyethylene glycol ("PEGylated"). It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in vitro.
Status:
US Previously Marketed
Source:
NATRECOR by SCIOS LLC
(2001)
Source URL:
First approved in 2001
Source:
NDA020920
Source URL:
Class:
PROTEIN
Conditions:
Nesiritide is the recombinant form of the 32 amino acid human B-type natriuretic peptide (BNP), which is normally produced by the ventricular myocardium. Human BNP binds to the particulate guanylate cyclase receptor of vascular smooth muscle and endothelial cells, leading to increased intracellular concentrations of guanosine 3'5'-cyclic monophosphate (cGMP) and smooth muscle cell relaxation. Cyclic GMP serves as a second messenger to dilate veins and arteries. Nesiritid was sold under brand name Natrecor for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity.
Status:
US Previously Marketed
Source:
GEREF by EMD SERONO INC
(1997)
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:
SARENIN by PROCTER AND GAMBLE
(1981)
Source URL:
First approved in 1981
Source:
SARENIN by PROCTER AND GAMBLE
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Saralasin is an angiotensin II analogue which was developed for the treatment of hypertension in 1970s. For many years saralasin was supposed to be angiotensin receptors blocker, but recent studies have revealed that its pharmacological action can be explained by agonistic behavior toward angiotensin II receptor. The drug was approved by FDA under the name Sarenin, however, it is no longer available on the market.
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:
US Previously Marketed
Source:
FACTREL by HIKMA
(1982)
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
Source:
FACTREL by HIKMA
(1982)
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
First approved in 2014
Source:
21 CFR 352
Source URL:
Class:
PROTEIN
Targets:
Thymopentin is a synthetic pentapeptide which is the active site of the naturally occurring hormone thymopoietin with immunomodulating properties. Thymopentin can specifically promote the differentiation and maturation of thymic T cells and natural killer cells (NK) and enhance the function of T helper cells. thymic can achieve a two-way adjustment to the immune system by increasing the levels of intracellular cyclic adenosine monophosphate, elevating the activity of T cells, and regulating the proportions of T cell subsets. As an immunomodulating agent, Thymopentin is clinically used in the treatments of autoimmune diseases, such as e.g. atopic dermatitis, chronic lymphocytic leukemia, Sezary's syndrome, rheumatoid arthritis, as well as decreased immune competency in elder surgical patients. Due to poor membrane permeability, extensive metabolism in the GI, and extremely short half-life of 30 s, repeated injections or i.v infusions of Thymopentin are necessary which greatly restrict its clinical applications.
