Seysara

Product manufactured by Almirall, Llc

Application Nr Approved Date Route Status External Links
NDA209521 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Seysara® (Sarecycline) Tablet, Is Indicated For The Treatment Of Inflammatory Lesions Of Non-Nodular Moderate To Severe Acne Vulgaris In Patients 9 Years Of Age And Older. Limitations Of Use Efficacy Of Seysara Beyond 12 Weeks And Safety Beyond 12 Months Have Not Been Established. Seysara Has Not Been Evaluated In The Treatment Of Infections [See Clinical Studies ( 14 )] . To Reduce The Development Of Drug-Resistant Bacteria As Well As To Maintain The Effectiveness Of Other Antibacterial Drugs, Seysara Should Be Used Only As Indicated [See Warnings And Precautions ( 5.6 )] . Seysara ® Is A Tetracycline-Class Drug Indicated For The Treatment Of Inflammatory Lesions Of Non-Nodular Moderate To Severe Acne Vulgaris In Patients 9 Years Of Age And Older. ( 1 ) Limitations Of Use Efficacy Of Seysara Beyond 12 Weeks And Safety Beyond 12 Months Have Not Been Established. Seysara Has Not Been Evaluated In The Treatment Of Infections. To Reduce The Development Of Drug-Resistant Bacteria As Well As To Maintain The Effectiveness Of Other Antibacterial Drugs, Seysara Should Be Used Only As Indicated [See Warnings And Precautions ( 5.6 )].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sarecycline Hydrochloride SARECYCLINE HYDROCHLORIDE ZINC72319783

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