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Details for New Drug Application (NDA): 205353
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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: | Secura |
Ingredient: | panobinostat lactate |
Patents: | 5 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 205353
Generic Entry Date for 205353*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | 0078-0650-06 | 6 CAPSULE in 1 BLISTER PACK (0078-0650-06) |
FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353 | NDA | Novartis Pharmaceuticals Corporation | 0078-0651 | 0078-0651-06 | 6 CAPSULE in 1 BLISTER PACK (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: | Start Trial | Patent Expiration: | Aug 31, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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