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Details for New Drug Application (NDA): 022150

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NDA 022150 describes FIRAZYR, which is a drug marketed by Shire Orphan Therap and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the FIRAZYR profile page.

The generic ingredient in FIRAZYR is icatibant acetate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the icatibant acetate profile page.

Summary for NDA: 022150

Tradename:
FIRAZYR
Applicant:
Shire Orphan Therap
Ingredient:
icatibant acetate
Patents:1

Pharmacology for NDA: 022150

Suppliers and Packaging for NDA: 022150

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIRAZYR
icatibant acetate
INJECTABLE;SUBCUTANEOUS 022150 NDA Shire US Manufacturing Inc. 54092-702 54092-702-01 1 SYRINGE, GLASS in 1 CARTON (54092-702-01) > 3 mL in 1 SYRINGE, GLASS
FIRAZYR
icatibant acetate
INJECTABLE;SUBCUTANEOUS 022150 NDA Shire US Manufacturing Inc. 54092-702 54092-702-02 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) > 3 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Aug 25, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 25, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 25, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:5,648,333Patent Expiration:Jul 15, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATHOLOGICAL STATE BY ANTAGONIZING BRADYKININ RECEPTOR INCLUDING TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE)


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