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FDA Accepts Pain Drug for Review

[ Price : $8.95]

FDA accepts for review a Pacira Pharmaceuticals NDA for Exparel (bupivacaine), a long-acting drug for postsurgical pain management...

Vivus Responds to FDA Qnexa Letter

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Vivus says it has responded to points raised in an FDA complete response letter on its obesity drug Onexa.

Life Sciences Waiting on Social Media Rules

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Deloitte Research says some life-science hesitation over using social networks may involve a misperception of how best they can be...

FDA Gives Extension on Chronic Fatigue NDA Resubmission

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FDA grants a 12-month extension to Hemispherx Biopharma for the company to modify its NDA in response to a 11/25/09 complete respo...

FDA Approves New Dosing on HIV Combo Drug

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FDA approves a Tibotec Therapeutics supplemental NDA that revises the dosing recommendation to include once-daily Prezista (daruna...

FDA Warns of Accidental Benzonatate Ingestion

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FDA warns that accidentally ingesting branded and generic forms of benzonatate by children under age 10 can lead to overdose and d...

Lilly Investigational Melanoma Drug on Clinical Hold

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Eli Lilly suspends for safety reasons a global Phase 3 study evaluating tasisulam, an investigational, anti-cancer compound for us...

Review Period Set for Freestyle Navigator

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Federal Register Notice: FDA determines the regulatory review period for Abbotts Freestyle Navigator for the purpose of patent ext...

Samsca Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for Otsuka Pharmaceuticals Samsca.

Vibativ Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for Theravance Inc.s Vibativ for the purpose of patent extens...