FDA Endocrinology and Metabolic Drugs Advisory Committee Split on Approvability of Sotagliflozin Oral Tablet for Diabetes

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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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Welcome To The FDA Blog At ISS!

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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

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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

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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)

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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

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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

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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

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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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FDA Advisory Committee on the Safety of Celecoxib, Naproxen and Ibuprofen

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On April 24th – April 25th, 2018 a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Committee convened to review supplemental new drug application (sNDA) 0209998/S-050 for Pfizer Pharmaceuticals’ COX-2 inhibitor Celecoxib (Celebrex). Celebrex is an oral tablet that can be used as an analgesic and for swelling and inflammation.
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FDA Advisory Committee in Favor of 2 mg dose and Opposed to 4 mg dose of Eli Lilly’s Baricitinib

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On April 23, 2018 a meeting of the Arthritis Advisory Committee took place to review new drug application (NDA) 207924 sponsored by Eli Lilly and Company. The new molecular entity, baricitinib, is a Janus associated kinase inhibitor proposed for the treatment of active rheumatoid arthritis in adults who have not had an appropriate response to
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