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Listed Dossiers
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Drugs in Development
Details:
The CRL indicates that the FDA has completed its review of the NATPARA, is a prescription parathyroid hormone PAS and determined that it cannot be approved in its present form.
Lead Product(s): Parathyroid Hormone,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Natpara
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 22, 2022
Lead Product(s) : Parathyroid Hormone,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Takeda Provides NATPARA Regulatory Update
Details : The CRL indicates that the FDA has completed its review of the NATPARA, is a prescription parathyroid hormone PAS and determined that it cannot be approved in its present form.
Product Name : Natpara
Product Type : Hormone
Upfront Cash : Inapplicable
March 22, 2022
Details:
Recombinant Human Parathyroid Hormone (1-84) is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hypoparathyroidism.
Lead Product(s): Recombinant Human Parathyroid Hormone (1-84),Parathyroid Hormone
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 25, 2016
Lead Product(s) : Recombinant Human Parathyroid Hormone (1-84),Parathyroid Hormone
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Recombinant Human Parathyroid Hormone (1-84) is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hypoparathyroidism.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
May 25, 2016
Details:
Parathyroid Hormone is a Hormone drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.
Lead Product(s): Parathyroid Hormone,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Takeda Pharmaceutical | Aarhus University Hospital
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 08, 2011
Lead Product(s) : Parathyroid Hormone,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Takeda Pharmaceutical | Aarhus University Hospital
Deal Size : Inapplicable
Deal Type : Inapplicable
Treatment With PTH After Sternotomy in Cardiac Surgery Patients
Details : Parathyroid Hormone is a Hormone drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Inapplicable
November 08, 2011
Details:
Parathyroid Hormone is a Hormone drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypoparathyroidism.
Lead Product(s): Parathyroid Hormone,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: NPS PHARMS INC | SHIRE PLC
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 13, 2010
Lead Product(s) : Parathyroid Hormone,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : NPS PHARMS INC | SHIRE PLC
Deal Size : Inapplicable
Deal Type : Inapplicable
HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism
Details : Parathyroid Hormone is a Hormone drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypoparathyroidism.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Inapplicable
September 13, 2010
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info :
Registration Country : USA
Brand Name : NATPARA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 25MCG
Packaging :
Approval Date :
Application Number : 125511
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : NATPARA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MCG
Packaging :
Approval Date :
Application Number : 125511
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : NATPARA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 75MCG
Packaging :
Approval Date :
Application Number : 125511
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : NATPARA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 100MCG
Packaging :
Approval Date :
Application Number : 125511
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Natpar
Dosage Form : Solution For Injection
Dosage Strength : 100mcg/dose
Packaging :
Approval Date : 24/04/2017
Application Number : 20141205000144
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Natpar
Dosage Form : Solution For Injection
Dosage Strength : 25mcg/dose
Packaging :
Approval Date : 24/04/2017
Application Number : 20141205000113
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Natpar
Dosage Form : Solution For Injection
Dosage Strength : 50mcg/dose
Packaging :
Approval Date : 24/04/2017
Application Number : 20141205000120
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Natpar
Dosage Form : Solution For Injection
Dosage Strength : 75mcg/dose
Packaging :
Approval Date : 24/04/2017
Application Number : 20141205000137
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Natpar
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 50MCG
Packaging :
Approval Date : 2018-02-12
Application Number : 1151078002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Preotact
Dosage Form : Solution For Injection
Dosage Strength : 100mcg
Packaging :
Approval Date : 24/04/2006
Application Number : 20050525000027
Regulatory Info : Deregistered
Registration Country : Sweden
Portfolio PDF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
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