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Cefzil Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Corden Pharma Latinas Cefzil (cefprozil) tablets, 250mg and 500mg mg, and Cefzil for ...

FDA Approves Tevas Opioid Dependence Drug

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FDA approves a Teva 505(b)(2) NDA for Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid...

More Data Needed on Glaxo COPD Add-on Drug

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FDA issues GlaxoSmithKline a complete response letter for its supplemental BLA for mepolizumab as an add-on treatment to inhaled c...

Masimo Acoustic Respiration Sensor for Infants Cleared

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FDA clears a Masimo 510(k) for the RAS-45, an acoustic respiration sensor for its Rainbow Acoustic Monitor (RAM) for infant and ne...

Members Sought for Mammography Quality Panel

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Federal Register notice: FDA requests nominations for voting members to serve on CDRHs National Mammography Quality Assurance Advi...

FDA Extends Review of Tecentriq sBLA

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FDA extends by three months the review of a Genentech supplemental BLA for Tecentriq (atezolizumab) for use in combination with Av...

Guide on Dietary Supplement Microbial Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding Quantitative Labeling of Dietary Supplemen...

Labeling Changes to 3 HIV Drugs

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FDA approves labeling changes for three ViiV HIV drugs containing dolutegravir to address risk of neural tube defects.

Court Dismisses PhRMA Drug Price Suit

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A California federal court dismisses PhRMAs suit against a state drug pricing transparency law and gives the association an opport...

Surgical Innovation Mesh for Cosmetic Surgery Cleared

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FDA clears a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of advanced bioabsorbable technologies f...