The FDA also made additional observations on various aspects of Vanda's sNDA
supports a potential new indication for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either:
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 10, 2019 for its review of the sNDA
Global healthcare company Novo Nordisk A/S (CPH:NOVOB) announced on Wednesday the submission of two New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) analogue in a tablet, as well as a supplemental NDA (sNDA
) for once-weekly Ozempic (semaglutide).
Subsequently the board formed a special committee of independent directors which is authorised to consider the SNDA
Proposal and other alternative proposals or competing offers and make recommendations to the board; and Shanda Interactive sold all ordinary shares of the company held by it to various parties, including Ningxia and its affiliates and Yili, and informed the company that it did not intend to remain a member of the SNDA
announced today that Sonitrol Pacific employees Technician John Provost, Technician Dean Packard, Operator Cami Halstead, Administrative Support Specialist Anne Ogama and Administrative Support Specialist Salena Wolfe all earned honors in their respective categories.
"The acceptance of the sNDA
underscores our ongoing commitment to provide innovative therapies for patients living with debilitating central nervous system disorders," said Troy Cox, President CNS Operations, UCB.
Roche is optimistic that the FDA will complete its review of the sNDA
is expected to expand the Xyrem label to include the reduction of excessive daytime sleepiness (EDS) and the improvement in fragmented nighttime sleep in narcolepsy patients.
Food and Drug Adminis-tration has approved a supplemental new drug application (sNDA
) for VALTREX[R] (valacyclovir HCI) caplets in the treatment of cold sores in healthy adults.
Results of a multicenter, randomized, double-blind, placebo-controlled pediatric study were included in the supplemental New Drug Application (sNDA
) submission to the FDA in March 2001.
Amarin said Thursday after the market close that it was notified by the FDA of the agency's intention to hold an Adcom meeting for its sNDA
that seeks a label expansion for Vascepa, its fish oil pill.