Details for New Drug Application (NDA): 207356
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NDA 207356 describes ARIKAYCE KIT, which is a drug marketed by Insmed Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the ARIKAYCE KIT profile page.
The generic ingredient in ARIKAYCE KIT is amikacin sulfate. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
The generic ingredient in ARIKAYCE KIT is amikacin sulfate. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
Summary for 207356
| Tradename: | ARIKAYCE KIT |
| Applicant: | Insmed Inc |
| Ingredient: | amikacin sulfate |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207356
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356 | NDA | Insmed Incorporated | 71558-590 | 71558-590-28 | 28 VIAL in 1 CARTON (71558-590-28) / 8.4 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, LIPOSOMAL;INHALATION | Strength | EQ 590MG BASE/8.4ML | ||||
| Approval Date: | Sep 28, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 28, 2030 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Sep 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 15, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN | ||||||||
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