Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

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Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare
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FDA Panel Recommends Icosapent Ethyl (Vascepa) for Cardiovascular Risk Reduction

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The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on November 14th to review a supplemental New Drug Applications (sNDA) for icosapent ethyl, which is currently indicated for triglyceride reduction in patients in very high triglyceride levels. The meeting discussed the sNDA by the applicant Amarin Pharmaceuticals Ireland Limited, which would expand the label of
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Panel Does Not Recommend Expanding the Indicated Population for Empagliflozin (Jardiance)

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The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on November 13th to discuss the Boehringer Ingelheim Pharmaceuticals, Inc supplemental New Drug Application (sNDA) 204629/S-020 for empagliflozin. The sNDA seeks to expand the  indicated use of empagliflozin, 10-25mg/day, for glycemic control / cardiovascular risk reduction in patients with type-II diabetes to  include type-I diabetes as
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FDA Panel Recommends Approval of Nintedanib for Systemic Sclerosis

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The Arthritis Advisory Committee (AAC) met on July 25th to review the supplemental New Drug Application (sNDA) 205832 for nintedanib capsules by the applicant: Boehringer Ingelheim.  The panel evaluated the proposed indication for treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). Systemic Sclerosis (SSc) is a rare, multisystem connective tissue disease. It creates microvascular damage
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FDA Advisory Committee in Favor of Mannitol Inhalation Powder

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On May 8th, 2019 the Pulmonary-Allergy Drugs Advisory Committee (PADAC) convened to review the new drug application (NDA) #202049 for Bronchitol (mannitol inhalation powder) sponsored by Chiesi USA, Inc. Bronchitol, an inhaled dry powder form of mannitol, is intended for the management of cystic fibrosis in adults to improve pulmonary function in conjunction with standard
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Oncologic Drugs Advisory Committee Supports Pexidartinib but Not Quizartinib

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The Oncologic Drugs Advisory Committee (ODAC) reviewed the new drug application (NDA) #211810 for perxidartinib and NDA # 212166 for quizartinib by Daiichi Sankyo on May 14th, 2019. Pexidartinib was evaluated for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients.  The intended use of quizartinib was for the treatment of Feline
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FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Endorse Esketamine

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On February 12th, 2019, Janssen Pharmaceuticals, Inc. discussed their New Drug Application (NDA) #211243 for Esketamine nasal spray during a joint meeting of the FDA’s DSaRM and PDAC. The proposed indication is for the maintenance of treatment-resistant depression (TRD). The sponsor explained that TRD occurs when patients diagnosed with major depressive disorder (MDD) are unresponsive
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Pretomanid NDA for Drug-Resistant TB reviewed by FDA’s Antimicrobial Drugs Advisory Committee

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On June 6th, 2019, the Antimicrobial Drugs Advisory Committee convened to discuss the new drug application (NDA) # 212862 with the sponsor company: The Global Alliance for TB Drug Development, Inc. The NDA seeks approval of pretomanid (PA-824) in combination with the antibacterial drugs bedaquiline and linezolid for the treatment of drug-resistant or intolerant tuberculosis
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