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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FDA Joint Committee Recommends Approval of Uloric (Febuxostat) Tablets

Posted by on June 21, 2019

On January 11th, 2019, Takeda Pharmaceuticals appeared before a joint session of the Arthritis Advisory and the Drug Safety and Risk Management Advisory Committees. They were seeking approval for their supplemental new drug application for Uloric tablets (sNDA 021-856). Uloric, a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout,
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FDA Endocrinology and Metabolic Drugs Advisory Committee Split on Approvability of Sotagliflozin Oral Tablet for Diabetes

Posted by on June 14, 2019

On January 17th, 2019, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) reviewed the New Drug Application (NDA) 210934 sotagliflozin (Sanofi-Aventis U.S., LLC.) which seeks approval of sotagliflozin as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. Sotagliflozin is a dual inhibitor of sodium-glucose cotransporter 1 (SGLT1)
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Pretomanid NDA for Drug-Resistant TB reviewed by FDA’s Antimicrobial Drugs Advisory Committee

Posted by on June 7, 2019

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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Welcome To The FDA Blog At ISS!

Posted by on June 7, 2019

Innovative Science Solutions (ISS) is a consulting firm with over two decades of experience in the regulatory industry.  As one of the leaders in regulatory submissions and drug-related FDA Advisory Committee Meeting (AdComm) support, ISS has designed this blog to give you the most up to date information on a wide array of FDA topics. 
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FDA Advisory Committee Against Extended Release Oxycodone Capsules

Posted by on July 28, 2018

On June 26th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee reviewed New Drug Application (NDA) 022324 for extended release oxycodone capsules (Remoxy ER) by Pain Therapeutics Inc. Remoxy ER is an abuse deterrent, pain relief medication for those with severe enough
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FDA Advisory Committee Opposed to Buprenorphine Sublingual Spray

Posted by on July 27, 2018

On May 22nd, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee discussed the new drug application (NDA) 209588 for buprenorphine sublingual spray (Buvaya), submitted by INSYS Development Company Inc. The drug is an opioid receptor indicated for the treatment of moderate-to-severe
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