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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FDA Advisory Committee Votes in Favor of WAYLIVRA (volanesorsen)

Posted by on July 27, 2018

On May 10th, 2018 the Endocrinologic and Metabolic Drugs Advisory Committee met to review new drug application (NDA) 210645, for Akcea Therapeutics’ volanesoren. The drug is a subcutaneous injection proposed as an adjunct to diet for the treatment of familial chylomicronemia syndrome (FCS). A starting dose of 300 mg once weekly with dose adjustments based
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FDA Advisory Committee Against InfaCare Pharmaceutical Corporation’s Stannsoporfin

Posted by on July 25, 2018

On May 3rd, 2018 a joint meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee was held to discuss the new drug application (NDA) 209904 for InfaCare Pharmaceutical Corporation’s stannsoporfin. Stannsoporfin is administered via intramuscular injection for the treatment of neonates, 35 weeks of gestational age and older, with indicators of hemolysis
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FDA Advisory Committee Split on Indications for Achaogen’s Plazomicin

Posted by on July 24, 2018

On May 2nd, 2018 the Antimicrobial Drugs Advisory Committee convened to review new drug application (NDA) 210303, for plazomicin, sponsored by Achaogen Inc. Plazomicin is an aminoglycoside antibacterial drug proposed for in the treatment of complicated urinary tract infections (cUTI) and blood stream infections (BSI) in patients 18 years or older, with limited or no
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FDA Advisory Committee Unanimously Supports SIGA Technologies’ Tecovirimat

Posted by on July 23, 2018

On May 1st, 2018 the Antimicrobial Drugs Advisory Committee reviewed the new drug application (NDA) 208627 for SIGA Technologies’ tecovirimat, proposed for the treatment of smallpox caused by the variola virus, in pediatrics and adults.  The drug inhibits the production of extracellular viral forms responsible for the spread of infection within the body. Although smallpox
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