How to apply for an FDA Coronavirus Emergency Use Authorization Letter

Posted by on May 27, 2020

Applying for a COVID-19 Emergency Use Authorization (EUA) Letter from FDA is no small feat, even though FDA has tried to simplify the process.
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OTC Monograph Drug Reform Changes the Pharmaceutical Landscape

Posted by on April 23, 2020

On March 27, 2020, Congress and the House of Representatives with the support of the President signed into law a $2 trillion stimulus bill to address the dramatic economic impact caused by the coronavirus pandemic. Better known as the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the bill includes a provision for over-the-counter
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FDA Antimicrobial Drugs Advisory Committee Meeting (AMDAC) Recommends Approval of FETROJA (cefiderocol lyophilized powder)

Posted by on February 7, 2020

On October 16th, 2019, the Antimicrobial Drugs Advisory Committee (AMDAC) reviewed the New Drug Application (NDA) 209445 for cefiderocol lyophilized powder (Shionogi Inc.) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options. FETROJA is a cephalosporin antibacterial drug product consisting
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FDA Panel Recommends Icosapent Ethyl (Vascepa) for Cardiovascular Risk Reduction

Posted by on November 18, 2019

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)

Posted by on November 18, 2019

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

Posted by on August 22, 2019

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 Approves Selinexor Despite Panel’s Vote To Delay

Posted by on August 6, 2019

On February 26th, 2019, the Oncologic Drugs Advisory Committee assembled to determine the fate of Karyopharm Therapeutics’ latest drug, Selinexor (NDA 212306). Selinexor, an oral XPO1 inhibitor, is formulated to be used in combination with dexamethasone, for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and
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FDA Advisory Committee in Favor of Mannitol Inhalation Powder

Posted by on July 29, 2019

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

Posted by on July 24, 2019

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

Posted by on July 24, 2019

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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