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Details for New Drug Application (NDA): 205353
NDA 205353 describes FARYDAK, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the FARYDAK profile page.
The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the panobinostat lactate profile page.
The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the panobinostat lactate profile page.
Summary for 205353
| Tradename: | FARYDAK |
| Applicant: | Novartis Pharms Corp |
| Ingredient: | panobinostat lactate |
| Patents: | 5 |
Pharmacology for NDA: 205353
| Mechanism of Action | Histone Deacetylase Inhibitors Cytochrome P450 2D6 Inhibitors |
Suppliers and Packaging for NDA: 205353
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353 | NDA | Novartis Pharmaceuticals Corporation | 0078-0650 | N | 0078-0650-06 |
| FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353 | NDA | Novartis Pharmaceuticals Corporation | 0078-0651 | N | 0078-0651-06 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Feb 23, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 23, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 23, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR REGIMENS, INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Aug 31, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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