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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | Start Trial | Start Trial | TREATMENT OF SPINAL MUSCULAR ATROPHY | ||||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN | |||
| Global Blood Theraps | OXBRYTA | voxelotor | TABLET;ORAL | 213137-001 | Nov 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | TREATMENT OF SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR, AS RECITED IN CLAIM 1 | ||||
| Global Blood Theraps | OXBRYTA | voxelotor | TABLET;ORAL | 213137-001 | Nov 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | TREATMENT OF SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR, AS RECITED IN CLAIM 2 | ||||
| Acrotech | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | ||||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-002 | Mar 19, 2020 | RX | Yes | No | Start Trial | Start Trial | FOR THE TREATMENT OF HEPATITIS C | ||||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-002 | Mar 19, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |
