Regulatory Exclusivity: ORPHAN DRUG EXCLUSIVITY
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Drugs with Orphan Drug Exclusivity Regulatory Exclusivity
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-002 | Nov 22, 2022 | RX | Yes | No | ⤷ Sign Up | 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) | |
| Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-001 | Mar 6, 2015 | RX | Yes | Yes | ⤷ Sign Up | TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER | |
| Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-001 | Mar 6, 2015 | RX | Yes | Yes | ⤷ Sign Up | TREATMENT OF INVASIVE ASPERGILLOSIS | |
| Astellas | CRESEMBA | isavuconazonium sulfate | POWDER;INTRAVENOUS | 207501-001 | Mar 6, 2015 | RX | Yes | Yes | ⤷ Sign Up | TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER | |
| Astellas | CRESEMBA | isavuconazonium sulfate | POWDER;INTRAVENOUS | 207501-001 | Mar 6, 2015 | RX | Yes | Yes | ⤷ Sign Up | TREATMENT OF INVASIVE ASPERGILLOSIS | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
