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Merck: FDA reviewing tablet to eliminate allergy
2013-03-27 18:30:45| Biotech - Topix.net
Drugmaker Merck & Co. says federal regulators are reviewing its application to sell a new type of treatment for grass pollen allergy that gradually reduces allergy symptoms over time, rather than just temporarily relieving the sneezing and itching.
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Merck Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet
2013-03-27 13:00:00| 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, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT. Language: English Contact HTML: MerckMedia:Pam Eisele, (908) 423-5042Tracy Ogden, (267) 305-2301orInvestors:Justin Holko, (908) 423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
license
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grass
FDA OKs Merck OTC version of overactive bladder drug
2013-01-26 07:43:40| Biotech - Topix.net
Health regulators approved Merck & Co's nonprescription version of Oxytrol to treat overactive bladder in women ages 18 and older, the agency said on Friday.
Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection
2013-01-07 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, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDAs review to be completed in the first half of 2013. Language: English Contact HTML: MerckMedia Contacts:Pam Eisele, 908-423-5042Lainie Keller, 908-423-4187orInvestor Contact:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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drug
acceptance
injection
Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets
2013-01-02 22:45:00| 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 U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine. The updated NDA was deemed complete for review after Merck submitted additional data in response to the FDAs Complete Response Letter issued last year. Language: English Contact HTML: MerckMedia:Pamela Eisele, 908-423-5042orSkip Irvine, 267-305-5397orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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