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Details for New Drug Application (NDA): 203389
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NDA 203389 describes PROCYSBI, which is a drug marketed by Horizon Pharma Usa and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the PROCYSBI profile page.
The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for 203389
| Tradename: | PROCYSBI |
| Applicant: | Horizon Pharma Usa |
| Ingredient: | cysteamine bitartrate |
| Patents: | 10 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203389
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 203389
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Horizon Pharma Inc. | 75987-100 | 75987-100-04 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04) |
| PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Horizon Pharma Inc. | 75987-101 | 75987-101-08 | 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-101-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Apr 30, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 30, 2020 | ||||||||
| Regulatory Exclusivity Use: | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS IN ADULTS AND CHILDREN AGES 6 YEARS AND OLDER. | ||||||||
| Regulatory Exclusivity Expiration: | Feb 14, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 22, 2021 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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