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Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(20) weight control lysine hydrochloride
Source URL:
First approved in 1971
Source:
NDA016822
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lysing is an essential basic amino-acid encoded by codone AAA and AAG, and used in the biosynthesis of proteins. The daily requirement for lysine is 38 mg/kg body weight. The most rich source of lysine is fish, beef, chicken. In a clinical study lysine supplements was found to be an effective for reduction of occurrence, severity and healing time for recurrent HSV infection, however Cochrane Review concluded that the evidence is insufficient. Lysine was investigated for improving anxiety, ameliorating angina prectoris. Lysine acetylsalicylate has been used to treat pain and to detoxify the body after heroin use. Lysine clonixinate has been used for its analgesic properties for the treatment of migraine headaches and other painful conditions. However, limited clinical trials exist for these conditions.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(20) weight control lysine hydrochloride
Source URL:
First approved in 1971
Source:
NDA016822
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lysing is an essential basic amino-acid encoded by codone AAA and AAG, and used in the biosynthesis of proteins. The daily requirement for lysine is 38 mg/kg body weight. The most rich source of lysine is fish, beef, chicken. In a clinical study lysine supplements was found to be an effective for reduction of occurrence, severity and healing time for recurrent HSV infection, however Cochrane Review concluded that the evidence is insufficient. Lysine was investigated for improving anxiety, ameliorating angina prectoris. Lysine acetylsalicylate has been used to treat pain and to detoxify the body after heroin use. Lysine clonixinate has been used for its analgesic properties for the treatment of migraine headaches and other painful conditions. However, limited clinical trials exist for these conditions.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(20) weight control isoleucine
Source URL:
First approved in 1971
Source:
NDA016822
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Isoleucine is an essential α-amino acid that is used in the biosynthesis of proteins. L-isoleucine is commonly used in parenteral and enteral nutrition. It is used in combination with the other branched chain amino acids to improve the nutritional status of patients with hepatic diseases. BCAAs serve as important fuel sources for skeletal muscle during periods of metabolic stress
Status:
First approved in 1971
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Spectinomycin is an antibiotic produced by Streptomyces spectabilis. It is active against gram-negative bacteria and used for the treatment of acute gonorrheal urethritis and proctitis in the male and acute gonorrheal cervicitis and proctitis in the female when due to susceptible strains of Neisseria gonorrhoeae. In vitro studies have shown spectinomycin to be active against most strains of Neisseria gonorrhoeae (minimum inhibitory concentration <7.5 to 20 mcg/mL). Footprint studies indicate that spectinomycin exerts regional effects on ribosomal structure. Spectinomycin hydrochloride is an inhibitor of protein synthesis in the bacterial cell; the site of action is the 30S ribosomal subunit. The antibiotic is not significantly bound to plasma protein. Spectinomycin was discovered 1961. It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. This antibiotic is no longer available in the United States. Pfizer has discontinued distribution of spectinomycin (Trobicin) in the U.S. The drug continues to be distributed outside the U.S.
Status:
First approved in 1971
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Spectinomycin is an antibiotic produced by Streptomyces spectabilis. It is active against gram-negative bacteria and used for the treatment of acute gonorrheal urethritis and proctitis in the male and acute gonorrheal cervicitis and proctitis in the female when due to susceptible strains of Neisseria gonorrhoeae. In vitro studies have shown spectinomycin to be active against most strains of Neisseria gonorrhoeae (minimum inhibitory concentration <7.5 to 20 mcg/mL). Footprint studies indicate that spectinomycin exerts regional effects on ribosomal structure. Spectinomycin hydrochloride is an inhibitor of protein synthesis in the bacterial cell; the site of action is the 30S ribosomal subunit. The antibiotic is not significantly bound to plasma protein. Spectinomycin was discovered 1961. It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. This antibiotic is no longer available in the United States. Pfizer has discontinued distribution of spectinomycin (Trobicin) in the U.S. The drug continues to be distributed outside the U.S.
Status:
First approved in 1971
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Spectinomycin is an antibiotic produced by Streptomyces spectabilis. It is active against gram-negative bacteria and used for the treatment of acute gonorrheal urethritis and proctitis in the male and acute gonorrheal cervicitis and proctitis in the female when due to susceptible strains of Neisseria gonorrhoeae. In vitro studies have shown spectinomycin to be active against most strains of Neisseria gonorrhoeae (minimum inhibitory concentration <7.5 to 20 mcg/mL). Footprint studies indicate that spectinomycin exerts regional effects on ribosomal structure. Spectinomycin hydrochloride is an inhibitor of protein synthesis in the bacterial cell; the site of action is the 30S ribosomal subunit. The antibiotic is not significantly bound to plasma protein. Spectinomycin was discovered 1961. It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. This antibiotic is no longer available in the United States. Pfizer has discontinued distribution of spectinomycin (Trobicin) in the U.S. The drug continues to be distributed outside the U.S.
Status:
US Previously Marketed
Source:
GEOPEN by ROERIG
(1970)
Source URL:
First approved in 1970
Source:
GEOPEN by ROERIG
Source URL:
Class (Stereo):
CHEMICAL (EPIMERIC)
Targets:
Conditions:
Carfecillin is a phenyl ester of the side-chain carboxyl group of carbenicillin, beta-lactam antibiotic, acting as a prodrug. Upon oral administration, is broken down in the intestinal mucosa to the active antibacterial. It is used for urinary tract infections.
Status:
First approved in 1970
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Meprednisone, also known as NSC-63278 and Betapar, is a glucocorticoid receptor agonist.It has anti-inflammatory and immunosuppressive activity. It was approved since 1978, but its marketing in USA was discontinied since. Meprednisone is marketed in Argentina under trade name Copytren for treatment of rheumatic diseases, diseases of collagen, dermatological, gastrointestinal, respiratory and ophtalmological diseases.
Status:
US Previously Marketed
Source:
GEOPEN by ROERIG
(1970)
Source URL:
First approved in 1970
Source:
GEOPEN by ROERIG
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Targets:
Conditions:
Carfecillin is a phenyl ester of the side-chain carboxyl group of carbenicillin, beta-lactam antibiotic, acting as a prodrug. Upon oral administration, is broken down in the intestinal mucosa to the active antibacterial. It is used for urinary tract infections.
Status:
US Previously Marketed
Source:
SERENTIL by NOVARTIS
(1970)
Source URL:
First approved in 1970
Source:
SERENTIL by NOVARTIS
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Mesoridazine (brand name Serentil) is a phenothiazine antipsychotic. It was marketed in the U.S. for the treatment of schizophrenia, behavioral problems in mental deficiency and chronic brain syndrome, alcoholism and psychoneurotic symptoms, such as anxiety and tension. Due to the risk of serious cardiac events the indicated use of Serentil was limited to severely ill schizophrenic patients who fail other therapies. Based upon animal studies, mesoridazine acts indirectly on reticular formation, whereby neuronal activity into reticular formation is reduced without affecting its intrinsic ability to activate the cerebral cortex. Mesoridazine shows a moderate adrenergic blocking activity in vitro and in vivo and antagonizes 5-hydroxytryptamine in vivo.