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Generated: November 21, 2018

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Details for New Drug Application (NDA): 208685

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NDA 208685 describes EMFLAZA, which is a drug marketed by Ptc Therap and is included in two NDAs. It is available from two suppliers. Additional details are available on the EMFLAZA profile page.

The generic ingredient in EMFLAZA is deflazacort. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
Summary for 208685
Tradename:EMFLAZA
Applicant:Ptc Therap
Ingredient:deflazacort
Patents:0
Generic Entry Opportunity Date for 208685
Generic Entry Date for 208685*:
Constraining patent/regulatory exclusivity:
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
Dosage:
SUSPENSION;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: 208685
Suppliers and Packaging for NDA: 208685
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMFLAZA deflazacort SUSPENSION;ORAL 208685 NDA Marathon Pharmaceuticals, LLC 42998-505 42998-505-21 13 mL in 1 BOTTLE (42998-505-21)
EMFLAZA deflazacort SUSPENSION;ORAL 208685 NDA PTC Therapeutics, Inc. 52856-505 52856-505-21 13 mL in 1 BOTTLE (52856-505-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength22.75MG/ML
Approval Date:Feb 9, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 9, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 9, 2024
Regulatory Exclusivity Use:TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER

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