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Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection
2013-09-23 14:00:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application for sugammadex sodium injection, Mercks investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. Language: English Contact: Media:Pam Eisele, 908-423-5042orSarra Herzog, 908-423-6154orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck Receives Complete Response Letter for Suvorexant, Mercks Investigational Medicine for Insomnia
2013-07-01 14:00:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application for suvorexant, Mercks investigational medicine for the treatment of insomnia. In the Complete Response Letter, the FDA advised Merck that: Language: English Contact: MerckMedia Contacts:Steve Cragle, 415-845-1256orTracy Ogden, 267-305-2301orInvestor Contacts:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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A.P. Pharma Receives FDA Complete Response Letter For APF530
2013-03-28 08:00:00| dairynetwork Home Page
A.P. Pharma, Inc., a specialty pharmaceutical company, recently announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV).
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