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Search results for omidenepag root_references_citation in Reference Text / Citation (approximate match)
Status:
US Previously Marketed
Source:
RESCULA by SUCAMPO PHARMA LLC
(2000)
Source URL:
First approved in 2000
Source:
RESCULA by SUCAMPO PHARMA LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Unoprostone Isopropyl is a synthetic docosanoid and a structural analogue of an inactive biosynthetic cyclic derivative of arachidonic acid, 13,14-dihydro-15-keto-prostaglandin F 2a. Although the mechanism of action is unknown, unoprostone isopropyl is believed to reduce elevated intraocular pressure by increasing the outflow of aqueous humor through the trabecular meshwork. Unoprostone isopropyl (UI) may have a local effect on Big Potassium channels and ClC-2 chloride channels, but the exact mechanism is unknown at this time. Unoprostone is used for the management of open-angle glaucoma and ocular hypertension. The therapeutic efficacy of Unoprostone can be decreased when used in combination with Celecoxib, Diclofenac, Diflunisal, Etodolac and some other drugs. Unoprostone isopropyl ophthalmic solution may gradually increase the pigmentation of the iris, cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes, exacerbate active intraocular inflammation (e.g., uveitis), and cause macular edema. In clinical studies, the most common ocular adverse reactions with use of Rescula were burning/stinging, burning/stinging upon drug instillation, dry eyes, itching, increased length of eyelashes, and injection. These were reported in approximately 10–25% of patients. Ocular adverse reactions occurring in approximately 5–10% of patients were abnormal vision, eyelid disorder, foreign body sensation, and lacrimation disorder. Other adverse reactions occurred more rarely.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(v)(B) skin protectant:insect bites/stings w/ sales less than $25,000 isopropyl palmitate
Source URL:
First approved in 1996
Source:
Hydrocortisone Acetate Pramoxine Hcl by Padagis Israel Pharmaceuticals Ltd
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Isopropyl palmitate is the ester of isopropyl alcohol and palmitic acid. It is an emollient, moisturizer, thickening agent, and anti-static agent. Isopropyl Palmitate is a traditional, fast spreading emollient for modern cosmetic applications. Isopropyl palmitate is approved by ECOCERT for Natural and Organic Cosmetics. It is on FDA CFR - Code of Federal Regulations Title 21 list.
Status:
US Previously Marketed
Source:
67 FR 31123 vaginal contraceptive menfegol
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Menfegol-coated condom represents a new birth control method in which the contraceptive efficacy of the condom is enhanced by the spermicidal activity of menfegol. Menfegol possesses in vitro activity against human immunodeficiency virus (HIV). A randomized placebo-controlled safety study covered the use of menfegol foaming tablets for 14 days at increasing frequencies of insertion by 125 prostitutes in Dakar, Senegal. The frequencies of colposcopically diagnosed genital lesions were 5.0%, 11.8%, 27.8%, 49.7%, and 29.4% among menfegol recipients when tablets were used once every other day or 1, 2, 4, or 8 times a day, respectively (P < .05). Among placebo recipients, frequencies were 11.1% and 23.5% when tablets were used < 8 times daily and 8 times daily, respectively. There was no association between subjective genital symptoms and the incidence of colposcopically detected lesions. The high incidence of genital lesions when menfegol foaming tablets were used more than once daily suggests that their frequent use should not be recommended to prevent HIV transmission. In use at low frequency, the tablets' toxicity might be balanced by anti-HIV properties. Safety studies on vaginal microbicides should use objective methods, such as colposcopy, to assess the incidence of lesions.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2019)
Source URL:
First approved in 2019
Source:
21 CFR 347
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 348
(2018)
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2016)
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2019)
Source URL:
First approved in 2011
Source:
M016
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
ANDA078233
(2007)
Source URL:
First approved in 2007
Source:
ANDA078233
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Volu-Firm Night Treatment with Retinol
Source URL:
First approved in 2004
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions: