Details for New Drug Application (NDA): 210745
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NDA 210745 describes OTEZLA XR, which is a drug marketed by Amgen Inc and is included in one NDA. There are five patents protecting this drug. Additional details are available on the OTEZLA XR profile page.
The generic ingredient in OTEZLA XR is apremilast. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apremilast profile page.
The generic ingredient in OTEZLA XR is apremilast. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apremilast profile page.
Summary for 210745
| Tradename: | OTEZLA XR |
| Applicant: | Amgen Inc |
| Ingredient: | apremilast |
| Patents: | 5 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 75MG | ||||
| Approval Date: | Aug 29, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS | ||||||||
| Regulatory Exclusivity Expiration: | Jul 19, 2026 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
| Regulatory Exclusivity Expiration: | Jan 19, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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