Application Nr Approved Date Route Status External Links
NDA021951 2014-08-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Absorica Is A Retinoid Indicated For The Treatment Of Severe Recalcitrant Nodular Acne In Patients 12 Years Of Age And Older. Nodules Are Inflammatory Lesions With A Diameter Of 5 Mm Or Greater. The Nodules May Become Suppurative Or Hemorrhagic. “severe,” By Definition, Means “many” As Opposed To “few Or Several” Nodules. Because Of Significant Adverse Reactions Associated With Its Use, Absorica Should Be Reserved For Patients With Multiple Severe Nodular Acne Who Are Unresponsive To Conventional Therapy, Including Systemic Antibiotics. In Addition, Absorica Is Indicated Only For Those Female Patients Who Are Not Pregnant, Because Absorica Can Cause Severe Birth Defects [see Contraindications (4.1)]. Absorica Is A Retinoid Indicated For The Treatment Of Severe Recalcitrant Nodular Acne In Patients 12 Years Of Age And Older (1). Limitations Of Use Absorica May Only Be Administered To Patients Enrolled In The Ipledge Program (1, 5.2). Limitations Of Use A Single Course Of Therapy For 15 To 20 Weeks Has Been Shown To Result In Complete And Prolonged Remission Of Disease In Many Patients. If A Second Course Of Therapy Is Needed, It Should Not Be Initiated Until At Least 8 Weeks After Completion Of The First Course, Because Experience With Isotretinoin Has Shown That Patients May Continue To Improve Following Treatment With Isotretinoin. The Optimal Interval Before Retreatment Has Not Been Defined For Patients Who Have Not Completed Skeletal Growth [see Warnings And Precautions (5.12)]. As A Part Of The Ipledge Program, Absorica May Only Be Administered To Patients Enrolled In The Program [see Warnings And Precautions (5.2)].

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Propyl Gallate PROPYL GALLATE Molecular AOX-Antioxidant REG-Food additives for which a petition has been filed and a regulation issued.
2. Sorbitan Monooleate SORBITAN MONOOLEATE Molecular EMUL-Emulsifier REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Isotretinoin ISOTRETINOIN ZINC3792789

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