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              Lannett Company, Inc.

              • Development Update

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              UNITED STATES United States

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              CPhI North America Online

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              Lannett Submits ANDA For Generic ADVAIR DISKUS®

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              Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

              Highest Development Status: Phase IV Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 01, 2021

              Details:

              Respirent Pharmaceuticals has summited an Abbreviated New Drug Application for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the U.S. FDA. The product is the generic equivalent of ADVAIR DISKUS of GlaxoSmithKline.

              Insmed

              • Development Update

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              UNITED STATES United States

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              CPhI North America Online

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              Insmed Initiates Frontline Clinical Trial Program for ARIKAYCE® (amikacin liposome inhalation suspension) in Patients with MAC Lung Disease

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              Lead Product(s): Amikacin

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Arikayce

              Highest Development Status: Phase IV Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 04, 2021

              Details:

              First patient was dosed in late December, 2020, in the frontline clinical trial program of ARIKAYCE® (amikacin liposome inhalation suspension) in patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).

              Kaiser Permanente Washington Health Research

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              CPhI North America Online

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              Amarin Supports Investigator-Initiated Trial at Kaiser

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              Lead Product(s): Eicosapentaenoic Acid

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Vascepa

              Highest Development Status: Phase IV Product Type: Small molecule

              Partner/Sponsor/Collaborator: Amarin

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Collaboration August 07, 2020

              Details:

              Study aims to evaluate effects of icosapent ethyl (VASCEPA®) (IPE) on laboratory-confirmed viral upper respiratory infection (URI) rates, clinical impact and outcomes, especially with SARS-CoV-2 infection in adults with established atherosclerotic cardiovascular disease.

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