Duchesnay's pregnancy-related nausea and vomiting drug wins FDA nod | Eagle Pharma begins rolling NDA submission for heat stroke treatment | FDA issues warning to Supernus for misleading promotional video
November 14, 2016
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Duchesnay's pregnancy-related nausea and vomiting drug wins FDA nod
Duchesnay's Bonjesta, or doxylamine succinate and pyridoxine HCl extended-release tablets, has been approved by the FDA for use in treating nausea and vomiting in pregnant women who are unresponsive to conservative management. The drug will be sold in 100-count bottles.
eMPR.com (11/11) 
Eagle Pharma begins rolling NDA submission for heat stroke treatment
A rolling submission of a new-drug application for Ryanodex, or dantrolene sodium, has been initiated for FDA review by Eagle Pharmaceuticals. The firm is seeking approval for the drug as a treatment of exertional heat stroke.
Seeking Alpha (free registration) (11/11) 
FDA issues warning to Supernus for misleading promotional video
The FDA's Office of Prescription Drug Promotion has sent a letter to Supernus Pharmaceuticals, calling out its misleading promotional video suggesting that Oxtellar XR is indicated for epilepsy when it is indicated as an adjunct therapy for partial seizures. The video also minimized the drug's risks, which are serious and include anaphylactic reactions, hyponatremia and suicidal ideation.
FDAnews (11/11) 
Global Focus
Renewal of conditional approval for PTC's Duchenne drug endorsed by EMA panel
The renewal of the conditional marketing authorization for PTC Therapeutics' Translarna, or ataluren, has been endorsed by the European Medicines Agency's Committee for Medicinal Products for Human Use to treat Duchenne muscular dystrophy caused by a nonsense mutation in the dystrophin gene. The recommendation was based on available data, which the committee said showed that the drug poses no major safety risks and slows disease progression, but it is asking for more data to prove the benefit-risk balance.
Medscape (free registration) (11/11) 
EU grants conditional approval to Eli Lilly's soft tissue sarcoma drug
The European Union has granted a conditional marketing approval to Eli Lilly and Co.'s Lartruvo, or olaratumab, for use with doxorubicin as a treatment for advanced soft tissue sarcoma in patients for whom treatment with radiotherapy or surgery is not an option. The decision was backed by midstage trial data demonstrating that the combination treatment induced a median survival gain of 11.8 months in patients with the disease who had not previously been treated with doxorubicin.
PharmaTimes (U.K.) (11/11) 
9 drugs gain EMA panel backing
Nine treatments were endorsed for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use, including Novo Nordisk's Fiasp, Sanofi's Suliqua and Merck Sharp & Dohme's Lusduna to treat diabetes; Gedeon Richter's Terrosa and STADA Arzneimittel's Movymia to treat osteoporosis; Gilead's hepatitis B treatment Vemlidy; and generic drugs tadalafil and darunavir from Mylan for the treatment of pulmonary arterial hypertension and HIV-1 infection, respectively. The committee also recommended marketing authorization for CSL Behring's Afstyla to treat and prevent bleeding in hemophilia A patients.
Regulatory Focus (11/11) 
EU approves Janssen's treatment for Crohn's disease
Janssen's Stelara, or ustekinumab, has been approved by the European Commission as a treatment for moderately to severely active Crohn's disease in adults who did not respond adequately with a tumor necrosis factor alpha antagonist or conventional therapy or are contraindicated to such treatments.
Seeking Alpha (free registration) (11/11) 
Food & Dietary Supplements
Mislabeling, undeclared allergen causes recall of egg rolls
Approximately 1,710 pounds of egg rolls are being recalled by New York City-based Water Lilies Food because the products were labeled as pork egg rolls but actually contain shrimp, a major food allergen. The items recalled, World Menu Egg Rolls Pork, were shipped to a distribution center in Massachusetts and sold in 15-ounce boxes with a best-by date of July 2, 2017, the UPC code 6-88267-06951-2 and the establishment number EST. M21465A.
Food Poisoning Bulletin (11/11) 
Medical Devices
Thrombotic events risk prompts recall of Concert Medical's coronary guidewires
A recall was initiated by Concert Medical involving some lots of its Galeo Pro coronary guidewires. The recall was issued over concerns about the risk of serious injury or death from thrombotic events, such as blood clots, which can happen if the polytetrafluoroethylene coating separates or detaches from the device.
FDAnews (11/14) 
Hologic's Aptima HCV, HBV Quant assays win approval in Canada
Health Canada has given Hologic approval for its Aptima HCV and HBV Quant assays, which are designed for use in detection of hepatitis C RNA and hepatitis B DNA. The nucleic acid amplification tests complete the company's virology portfolio on the Panther system in Canada, supplementing the Aptima HIV-1 Quant assay.
Medical Devices Business Review (U.K.) (11/11) 
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