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FDA Accepts Lannett NDA for Topical Anesthetic

[ Price : $8.95]

FDA accepts for review a Lannett 505(b)(2) NDA for Numbrino (cocaine hydrochloride) topical solution, 4% and 10%, indicated for us...

68 ANDA Approvals Withdrawn: FDA

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Federal Register notice: FDA announces the withdrawal of 68 ANDAs from multiple applicants.

FDA Approves Cancer Biomarker Test

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FDA approves Foundation Medicines F1CDx next generation sequencing cancer biomarker test.

FDA Approves Mylans Herceptin Biosimilar

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FDA approves Mylans Ogivri (trastuzumab-dkst), the first biosimilar to Genentechs Herceptin, indicated for treating patients with ...

FTC Settles with Dietary Supplement Marketer

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Health Research Laboratories and its owner, Kramer Duhon, agree to settle charges brought by the Federal Trade Commission and the ...

Panel to Review Ciprofloxacin Dispersion for Inhalation NDA

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Federal Register notice: FDA announces a 1/11/2018 Antimicrobial Drugs Advisory Committee meeting. to review an NDA for ciprofloxa...

Meticorten Not Withdrawn Due to Safety/Effectiveness: FDA

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Federal Register notice: FDA determines that Scherings Meticorten (prednisone) tablets were not withdrawn from sale for reasons of...

FDA Proposes 510(k) Exemption for Surgical Apparel

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Federal Register notice: FDA announces its intent to exempt certain subtypes of surgical apparel from premarket notification requi...

Texas Man Sentenced for Selling Unapproved Subutramine

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A federal judge sentences a Corpus Christi, TX, man to 12 months in prison for selling online and in stores dietary supplements th...

FDA Sued Over Human Subject Protections

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The Center for Responsible Science asks a federal court to order FDA to grant its 2014 petition seeking improvements in clinical t...