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Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Bietaserpine is a derivative of a Rauwolfia alkaloid reserpine. It was used as an antihypertensive agent and marketed in the 1960s in France and Italy. Bietaserpine is believed to act by inhibiting VMAT receptors.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Rolitetracycline nitrate is an antibiotic formed by N-aminomethylation of the carboxamide group of tetracycline. Rolitetracycline passively diffuses through porin channels in the bacterial membrane and reversibly binds to the 30S ribosomal subunit, preventing binding of tRNA to the mRNA-ribosome complex, and thus interfering with protein synthesis. It is formulated for intravenous or intramuscular injections and is used in cases requiring high concentrations or when oral administration is impractical. In combinations with chloramphenicol and colistin, it is used as the eye drops for the treatment of external eye infections such as catarrhal conjunctivitis, purulent, trachoma, blepharitis, blepharoconjunctivitis, bacterial keratitis, septic corneal ulcers.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Tripamide is a new diuretic derived from a sulfonamide nucleus that has both antihypertensive and natriuretic properties. It is Na-K-Cl cotransporter inhibitor. The antihypertensive mechanism of tripamide is considered to be based on a mild saluretic action and a peripheral vasodilation action. Tripamide is an ingredient of Normonal in Japan, indicated for the treatment of essential hypertension.
Status:
Possibly Marketed Outside US
Class:
MIXTURE
Actinomycin C is an antibiotic complex composed of actinomycin C1, C2 and C3 and produced by Streptomyces chrysomallus.
Actinomycin C reversibly binds to DNA, interfering with the synthesis of RNA, prevention of RNA polymerase elongation and, consequently, with protein synthesis. Actinomycin C exert an inhibitory effect on gram-positive and gram-negative bacteria and on some fungi. However, the toxic properties of the Actinomycin C in relation to antibacterial activity is such as to preclude its use as antibiotics in the treatment of infectious diseases. Because Actinomycin C is cytotoxic, it has an antineoplastic effect which has been demonstrated in experimental animals with various types of tumor implant. This cytotoxic action is the basis for its use in the treatment of certain types of cancer.
Status:
US Previously Marketed
Source:
DIAPID by NOVARTIS
(1970)
Source URL:
First approved in 1970
Source:
DIAPID by NOVARTIS
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Lypressin is synthetic analog of porcine antidiuretic hormone vasopressin. Itis a cyclic nonapeptide that differs from Arg-vasopressin by one amino acid, containing Lys at residue 8 instead of Arg. Lypressin-containing nasal spray was used to treat diabetes insipidus, but its marketing by Sandoz (Novartis) was discontinued.
Status:
Possibly Marketed Outside US
Class:
PROTEIN
Targets:
Conditions:
Felypressin is a non-catecholamine vasoconstrictor that is chemically related to vasopressin, the posterior pituitary hormone. Felypressin is added to some local anesthetics such as prilocaine in a concentration of 0.03 IU/ml. Its antidiuretic effects are less than those of vasopressin. Felypressin is used as a vasoconstrictor in local anesthetic injections for dental use and is an ingredient of preparations that have been used for the treatment of pain and inflammation of the mouth.
Status:
US Approved Rx
(2023)
Source:
ANDA216517
(2023)
Source URL:
First approved in 1977
Class:
POLYMER
Tetraethylenepentamine (TEPA) is a low-molecular-weight linear polyamine exerting metal-chelating properties. TEPA is widely used in industrial applications. The principal hazards that arise in working with TEPA are those associated with similar organic amines; namely, a corrosive action on skin and eyes. TEPA biological activity was attributed to its effect on cellular Cu levels as (a) treatment with TEPA resulted in reduction of cellular Cu, and (b) excess of Cu reversed TEPA's activity and accelerated differentiation. TEPA was shown to attenuate the differentiation of ex vivo cultured hematopoietic cells resulting in preferential expansion of early progenitors. A phase I/II trial was performed to test the feasibility and safety of transplantation of CD133+ cord blood (CB) hematopoietic progenitors cultured in media containing stem cell factor, FLT-3 ligand, interleukin-6, thrombopoietin and TEPA. Transplanting a population of CD133+ CB cells which were expanded ex vivo for 21 days using SCF, FLT3, IL-6, TPO and the copper chelator TEPA (StemEx) was feasible. The expanded cells were well tolerated, with no infusion-related adverse events observed.
Status:
Possibly Marketed Outside US
Class:
POLYMER
Conditions:
Lentinan is a polysaccharide extracted from Shiitake mushrooms and used as an adjuvant therapeutic drug in treating patients with lung cancer in China. Lentinan is mainly composed of β-glucan with anti-tumor, anti-inflammatory, anti-diabetes properties, and other therapeutic properties. Lentinan was approved as an adjuvant for stomach cancer therapy in Japan in 1985. It is approved for treating multiple types of cancer, hepatitis, and other diseases in China. Lentinan is available as capsules, tablets, and injections. The capsules and tablets of lentinan is taken orally as a traditional medicine. Intravenous injection of lentinan is clinically approved and used in hospital with a dose of 1–1.5 mg/day. Low blood pressure, allergy, urgent appeal, and dizziness were the major side effects.
Status:
US Approved Rx
(2020)
Source:
NDA213036
(2020)
Source URL:
First approved in 2020
Source:
NDA213036
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Sodium artesunate, an artemisinin derivative, is used in malaria treatment. Artesunate, has been licensed in Thailand for the
treatment of falciparum malaria since 1990. It is a potent antimalarial drug that can reduce parasitaemia by 90% within 24 h of administration. Sodium artesunate was first isolated in China, it is a water soluble antimalaria used clinically in China.
Status:
US Approved Rx
(2020)
Source:
NDA213036
(2020)
Source URL:
First approved in 2020
Source:
NDA213036
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Sodium artesunate, an artemisinin derivative, is used in malaria treatment. Artesunate, has been licensed in Thailand for the
treatment of falciparum malaria since 1990. It is a potent antimalarial drug that can reduce parasitaemia by 90% within 24 h of administration. Sodium artesunate was first isolated in China, it is a water soluble antimalaria used clinically in China.