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Restrict the search for
benzoyl peroxide
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Status:
Possibly Marketed Outside US
Source:
M020
(2023)
Source URL:
First approved in 2010
Source:
M020
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2011)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Class:
POLYMER
Status:
US Approved OTC
Source:
21 CFR 358.710(b)(1) dandruff:seborrheic dermatitis coal tar
Source URL:
First marketed in 1921
Class:
STRUCTURALLY DIVERSE
Status:
Other
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(12)(iv)(A) laxative:stimulant laxative podophyllum resin (podophyllin)
Source URL:
First approved in 1990
Source:
Podocon 25 by Bryant Ranch Prepack
Source URL:
Class:
STRUCTURALLY DIVERSE
Conditions:
Podophyllum resin is the powdered mixture of resins removed from the May apple or Mandrake, a perennial plant of the northern and middle United States. The early colonists learned of themedical properties of the root from the Indians, and it was used as a cathartic in the firstUnited States Pharmacopoeia (1820). The resin, podophyllin, was first separated from Podophyllum by John King in 1835. Between 1863 and 1942, podophyllin was reported to be a cathartic, purgative, deobstruent, vermifuge, hydragogue, cholagogue, choleretic, andexpectorant.Itwas recommended, either alone or in combination with other herbs, for diseases of the liverandkidneys, for scrofula, syphilis, gonorrhea, obstructed menstruation, urinary obstruction, dropsy, and coughs. Currently Podophyllum resin is used as a medication to treat genital warts and plantar warts, including in people with HIV/AIDS. Common side effects include redness, itchiness, and pain at the site of use. Severe side effects may include vomiting, abdominal pain, confusion, bone marrow suppression, and diarrhea. It is not recommended for more than a small area at a time. Use during pregnancy is known to be dangerous to the baby.
Status:
US Approved Rx
(2021)
Source:
NDA214907
(2021)
Source URL:
First approved in 2021
Source:
NDA214907
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
OTL-0038 or OTL-38, a fluorescent-labelled folate receptor-α (FRα) targeted imaging agent that accumulates in vivo in tumor cells expressing FR. OTL38 is currently in ongoing Phase 3 clinical trial in ovarian cancer and successfully completed phase 2 clinical trial in lung cancer. OTL38 is being evaluated for its ability to help surgeons locate and remove hard-to-find cancerous lesions that are often widespread. In 2014, the OTL-38 molecule was granted orphan drug status which can be given to the maker of a drug that treats rare conditions or diseases and offers protection from competition for a period of time. In addition, OTL-38 was studied in phase II clinical trials in the Netherlands for the diagnosis of endometriosis.
Status:
US Approved Rx
(2020)
Source:
NDA212950
(2020)
Source URL:
First approved in 2020
Source:
NDA212950
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Temsavir (BMS-626529) is an attachment inhibitor (AI) in clinical development (administered as prodrug BMS-663068) that binds to HIV-1 gp120. Temsavir displays in vitro activity against HIV-1 envelopes with C-C chemokine receptor type 5 (CCR5-), C-X-C chemokine receptor type 4 (CXCR4), and dual tropism. It also is active against almost all HIV-1 subtypes tested except for subtype CRF01-AE and possibly group O. Temsavir can inhibit both CD4-induced and CD4-independent formation of the "open state" four-stranded gp120 bridging sheet, and the subsequent formation and exposure of the chemokine co-receptor binding site. This unique mechanism of action prevents the initial interaction of HIV-1 with the host CD4+ T cell, and subsequent HIV-1 binding and entry. Temsavir is administered as a phosphonooxymethyl ester prodrug (BMS-663068), which was developed to improve the solubility and dissolution of Temsavir. Temsavir is currently being investigated clinically through the use of the prodrug BMS-663068, and a Phase III study of BMS-663068 in HIV-1-infected treatment-experienced subjects is ongoing (NCT02362503).
Status:
US Approved Rx
(2020)
Source:
NDA212950
(2020)
Source URL:
First approved in 2020
Source:
NDA212950
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Temsavir (BMS-626529) is an attachment inhibitor (AI) in clinical development (administered as prodrug BMS-663068) that binds to HIV-1 gp120. Temsavir displays in vitro activity against HIV-1 envelopes with C-C chemokine receptor type 5 (CCR5-), C-X-C chemokine receptor type 4 (CXCR4), and dual tropism. It also is active against almost all HIV-1 subtypes tested except for subtype CRF01-AE and possibly group O. Temsavir can inhibit both CD4-induced and CD4-independent formation of the "open state" four-stranded gp120 bridging sheet, and the subsequent formation and exposure of the chemokine co-receptor binding site. This unique mechanism of action prevents the initial interaction of HIV-1 with the host CD4+ T cell, and subsequent HIV-1 binding and entry. Temsavir is administered as a phosphonooxymethyl ester prodrug (BMS-663068), which was developed to improve the solubility and dissolution of Temsavir. Temsavir is currently being investigated clinically through the use of the prodrug BMS-663068, and a Phase III study of BMS-663068 in HIV-1-infected treatment-experienced subjects is ongoing (NCT02362503).
Status:
US Approved Rx
(2020)
Source:
NDA212950
(2020)
Source URL:
First approved in 2020
Source:
NDA212950
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Temsavir (BMS-626529) is an attachment inhibitor (AI) in clinical development (administered as prodrug BMS-663068) that binds to HIV-1 gp120. Temsavir displays in vitro activity against HIV-1 envelopes with C-C chemokine receptor type 5 (CCR5-), C-X-C chemokine receptor type 4 (CXCR4), and dual tropism. It also is active against almost all HIV-1 subtypes tested except for subtype CRF01-AE and possibly group O. Temsavir can inhibit both CD4-induced and CD4-independent formation of the "open state" four-stranded gp120 bridging sheet, and the subsequent formation and exposure of the chemokine co-receptor binding site. This unique mechanism of action prevents the initial interaction of HIV-1 with the host CD4+ T cell, and subsequent HIV-1 binding and entry. Temsavir is administered as a phosphonooxymethyl ester prodrug (BMS-663068), which was developed to improve the solubility and dissolution of Temsavir. Temsavir is currently being investigated clinically through the use of the prodrug BMS-663068, and a Phase III study of BMS-663068 in HIV-1-infected treatment-experienced subjects is ongoing (NCT02362503).