Topic: Sepracor Inc.
Perrigo (Nasdaq: PRGO ) today announced that its licensor and supplier Synthon has received final approval from the U.S. Food and Drug...
Eszopiclone , marketed by Sepracor under the brand-name Lunesta , is a nonbenzodiazepine hypnotic agent (viz. All clinical trials of eszopiclone published so far are industry funded by the pharmaceutical manufacturer of eszopiclone, Sepracor . Eszopiclone (Lunesta) along with other "Z Drugs" including zolpidem (Ambien ...
In a large-scale Phase III study, OMNARIS HFA delivered in an aerosol nasal formulation propelled by HFA (hydrofluoroalkane), met its primary endpoint If Sepracor's development of OMNARIS HFA is successful and the FDA approves the product for use in the U ...
A federal judge has thrown out generic-drug maker Wockhardt Ltd.'s claim that Sepracor Inc. misled patent examiners by covering up rat study data related to sleep drug Lunesta, saying that the allegations were weakly pled and that the disputed data wasn ...
Johnson & Johnson's (JNJ) McNeil Consumer Healthcare Unit announced a voluntary recall of certain over-the-counter infants' and children's liquid medicines because of problems with quality. Bristol-Myers Squibb (BMY) said that the U.S. Food and Drug Administration notified it that it ...
Sepracor Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA, or Agency) has issued a Complete Response Letter to Sepracor's New Drug Application (NDA) for its antiepileptic ...
Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA) recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of ...
Sepracor Inc. and Dainippon Sumitomo Pharma Co., Ltd. (DSP) today announce the resignation of Adrian Adams as President and Chief Executive Officer and Director of Sepracor and as Executive Officer of DSP, effective immediately, and the appointment of Saburo Hamanaka as Chairman ...
Sepracor Inc. today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency now anticipates completing its review of the Stedesa (eslicarbazepine acetate) New Drug Application (NDA) on April 30, 2010, which is a ...
Among the new data presented were evaluations of hyponatremia, cardiac repolarization, metabolic parameters and rash in a pooled analysis of three Phase III studies of STEDESA. Sepracor Inc. today announced that clinical study data for STEDESAT (eslicarbazepine acetate; ESL) were presented during ...
