Ireland

Innocoll Holdings

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IRELAND Ireland

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Innocoll Holdings Limited Announces FDA Acceptance of New Drug Application for XARACOLL

Lead Product(s): Bupivacaine Hydrochloride

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 26, 2020

Details:

If approved, XARACOLL will be Innocoll's first commercially available product in the US.

Jazz Pharmaceuticals

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IRELAND Ireland

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Jazz Pharmaceuticals Announces FDA Acceptance of New Drug Application for JZP-258

Lead Product(s): Sodium Oxybate

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 25, 2020

Details:

JZP-258 represents between 1,000 and 1,500 milligrams daily reduction of sodium for patients currently treated with Xyrem, depending on the dose.

Innocoll Holdings

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IRELAND Ireland

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Innocoll Holdings Limited Resubmits New Drug Application to FDA for XARACOLL

Lead Product(s): Bupivacaine Hydrochloride

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 27, 2020

Details:

Innocoll anticipates a 6-month review by the FDA.

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Companies

Innocoll Holdings

Innocoll Holdings Limited Announces FDA Acceptance of New Drug Application for XARACOLL

Jazz Pharmaceuticals

Jazz Pharmaceuticals Announces FDA Acceptance of New Drug Application for JZP-258

Innocoll Holdings

Innocoll Holdings Limited Resubmits New Drug Application to FDA for XARACOLL