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FDA Action Alert: Sage, Jazz, Lexicon and Sanofi, AMAG Pharma, and Recro Pharma

Cambridge, Mass.-based mostly SAGE Therapeutics has a goal motion date of March 19 for its Zulresso (brexanolone) to deal with postpartum melancholy (PPD). Initially, the PDUFA date was December 19, 2018. However, the FDA prolonged the time. Sage had submitted a proposed Threat Analysis and Mitigation Methods (REMS) program with Parts to Guarantee Protected Use (ETASU) in response to the company’s request, which resulted within the extension.

If accepted, the drug is anticipated to be scheduled by the U.S. Drug Enforcement Administration (DEA), in step with different authorized GABAergic medicine. The DEA is then required to the problem an interim closing rule controlling the drug inside 90 days of approval. In consequence, that date has additionally been pushed again, assuming the FDA approves the drug, till June 2019.

Jazz Prescribed drugs and Its Solriamfetol for Narcolepsy or Sleep Apnea

Jazz Prescribed drugs, headquartered in Dublin, has a goal motion date of March 20 for solriamfetol to enhance wakefulness and cut back extreme daytime sleepiness in adults with narcolepsy or obstructive sleep apnea (OSA). This was additionally a 3-month extension from the different PDUFA date. The company determined that the unique New Drug Utility (NDA)’s draft labeling want sufficient revision to be a severe modification.

On the time of the extension, Jed Black, senior vice chairman, Sleep and CNS Drugs for Jazz, acknowledged, “We admire the chance to work with the FDA to finish the assessment course of as quickly as potential. We’re dedicated to addressing unmet wants in sleep medication and stay up for providing solriamfetol as a significant remedy possibility for sufferers residing with extreme daytime sleepiness related to narcolepsy or OSA.”

Lexicon Prescribed drugs and Sanofi’s Zynquista for Sort 1 Diabetes

Lexicon Prescribed drugs, primarily based in The Woodlands, Texas, and Paris-based mostly Sanofi, have a goal motion date of March 22 for Zynquista (sotagliflozin) to deal with kind one diabetes. The drug is an oral twin inhibitor of SGLT-1 and SGLT-2, proteins that affect glucose absorption within the intestines and kidneys. The NDA was constructed on knowledge from the inTandem medical trial program of three Part III scientific trials in about three,000 adults in poorly managed kind 1 diabetes. The medicine additionally being evaluated by the European Medicines Company (EMA). On Jan. 17, the FDA’s Endocrinologic and Metabolic Medication Advisory Committee voted eight to eight on the drug’s total advantages outweighing the dangers.

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