FDA accepts re-application for new drug listing of DUOBRII washes for local treatment of plaque psoriasis

recently,, aof Bausch Health, a dermatological prescription drug company, reported that the U.SFDA(which has accepted the DUOBRII detergent (octanobuttabuterate and his zarodin, also known as IDP-118) for local treatment of plaque-like psoriasis
new drug (re-application for listing)this application belongs to the FDADrug(Class II Reapply, PDUFA date d'Italia is February 15, 2019)about DUOBRII (IDP-118)DUOBRII (IDP-118) is a daily lotion consisting of a fixed dose of halogenbutisobutetic acid (a corticosteroid) and hezobutine (a type of vicarate) with a dual mechanism that can achieve greater efficacy at very low concentrations while reducing the stimulation of patients treated with a combination of corticosteroids and acetatehalibutaproscorate is an anti-inflammatory drug and a skin disease agent commonly used to treat psoriasisIt works by inducing phospholipidase A2 inhibitors, collectively known as LipocortinIt is speculated that these proteins control the biologicalof inflammatory agents of synthetic(such as prostaglandins and white trienes, by inhibiting the release of their common precursor scosofa tetraoleic acid) Peanut tetraoleic acid is released by membrane phospholipids by phospholipidase A2 However, the initial interaction is due to the drug binding to the cytoplasm corticosteroid receptor After binding to the receptor, the newly formed receptor-ligand complex translocation enters the nucleus and binds to many glucocorticoid reaction elements (GRE) in the target gene promoter region The DNA binding receptor then interacts with the underlying transcription factors to enhance the expression of specific target genes tazorotin is a precursor to the RAR agonist tazarotenic acid, which is used to treat psoriasis, acne and sunburn It regulates three important pathogenic factors in psoriasis by interacting with specific nuclear difovalic acid receptors (RARs) to regulate gene transcription. In June 2018, DUOBRII's initial application received a full response letter from the FDA (CRL), which did not specify any defects related to the clinical efficacy or safety of DUOBRII, nor did it have questions related to pharmacological research data (CMC), and CRL only noted problems with pharmacokinetic data based on this, the company communicated with the FDA and resubmitted the listing application after learning of the requested DUOBRII additional pharmacokinetic data