Search Results for hydrocodone

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FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children By Zachary Brennan - Published 11 January 2018

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Labeling

Tags: codeine, cough and cold, hydrocodone

Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling By Michael Mezher - Published 27 January 2016

Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Prescription drugs, Government affairs

Tags: Hydrocodone, Opioid epidemic, Schedule II, DEA, Drug Enforcement Agency

DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers By Alexander Gaffney, RAC - Published 21 August 2014

In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law.

Categories: News, US, Distribution, Generic drugs, Prescription drugs, Postmarket surveillance

Tags: DEA, Hydrocodone, Schedule II, Schedule III, Final Rule, Rescheduling, Hydrocodone Combination Products

FDA: State, Federal Efforts to Reduce Access to Zohydro 'Extremely Troubling' By Alexander Gaffney, RAC - Published 31 March 2014

Categories: US, FDA

Tags: Zohydro, Hydrocodone, Ban, Massachusetts, Latest News, pharmaceutical, drug

FDA Declares Mission (Almost) Accomplished on Removal of High-Dose Acetaminophen Products By Alexander Gaffney, RAC - Published 27 March 2014

Categories: US, FDA, CDER

Tags: Voluntary Removal, Acetaminphen, Removal, Painkiller, Hydrocodone, ANDA, Latest News, pharmaceutical, drug

Legislators Call for Government Investigation Into Industry Influence on FDA Approval of Painkiller By Alexander Gaffney, RAC - Published 27 March 2014

Categories: US, FDA

Tags: Zohydro, Legislators, Hydrocodone, Letter, House, OIG, Latest News, pharmaceutical, approval, drug

Pressure Mounts on FDA to Reconsider Approval of New Painkiller By Alexander Gaffney, RAC - Published 20 March 2014

Categories: US, FDA

Tags: Zohydro, Painkiller, Hydrocodone, Legislation, House, Latest News, Congress

Senator Looks to Bypass FDA and Remove Zohydro With Legislation By Alexander Gaffney, RAC - Published 14 March 2014

Categories: US, FDA

Tags: Zogenix, Joe Manchin, Zohydro, Hydrocodone, Legislation, Latest News, Senate

Attempt to Strengthen Restrictions on Hydrocodone Products Clears Second-to-Last Hurdle By Alexander Gaffney, RAC - Published 26 February 2014

Categories: US, FDA

Tags: Controlled Substances Act, CSA, Hydrocodone, DEA

Love and More Powerful Drugs: Senate Minority Leader Slams FDA Decision on Hydrocodone Product By Alexander Gaffney, RAC - Published 14 February 2014

Categories: US, FDA

Tags: Hydrocodone

FDA Looks to Reassess Hydrocodone Products By Alexander Gaffney - Published 08 June 2012

Categories: FDA

Tags: Controlled Substances Act, CSA, Hydrocodone, Benefit, DEA, Abuse, Meeting, Latest News, risk