FDA News and Views: 2017 Medical Product Innovation, Many “Firsts” for 2017 Drug Approvals, Opioid Cough and Cold medicines Safety Labeling – Drug and Device Digest

FDA BRIEF: Week of January 8, 2018

Dr. Scott Gottlieb

Reflections on a Landmark Year for Medical Product Innovation and Public Health Advances and Looking Ahead to Policy in 2018

Inspiring year of advances in both medicine and public health

  • A Record Year for New Innovation
  • Modernizing FDA’s Regulatory Programs
  • Promoting Drug Competition
  • New Steps to Combat Addiction
  • New Steps to Combat Addiction
  • Improving our Stewardship of Vital Drugs
  • Protecting and Empowering Consumers

pie chart of approvals

Chart of device approvals

2017 generics approvalsREAD


Many “Firsts” for CDER’s 2017 Drug Approvals Reflect Innovation and Enhanced Patient Care

Approved new treatments for patients with rare diseases

  • Batten disease
  • Chagas disease
  • Hemophilia A with inhibitors

Novel “Firsts” in treating

  • Liver cancer in almost a decade
  • Sickle cell diseasein almost 20 years
  • Giant cell arteritis
  • Cytokine release syndrome
  • Chronic graft versus host disease after a bone marrow transplant
  • Marginal zone lymphoma
  • Eosinophilic granulomatosis with polyangiitis
  • Erdheim-Chester Disease

Other firsts that are not novel drug approvals 

  • Biosimilars to treat certain cancers
  • Immediate-release opioid product with properties intended to deter abuse
  • Once-monthly injectable buprenorphine product for opioid addiction
  • Cancer treatment based on a genetic feature rather than location
  • Treatment to help prevent recurrence of renal cell carcinoma
  • Complete regimen to treat HIV-1 that contains only two drugs, neither a nucleoside reverse transcriptase inhibitor, which can be detrimental to a patient’s kidneys, bones, and heart;
  • Drug with a sensor embedded in pill to track medication compliance
  • Short-acting “follow-on” insulin product




FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

Safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old

  • Serious risks of these medicines outweigh potential benefits in population
  • Products will no longer be indicated for use to treat cough in pediatric population
  • Additional safety information for adult use – risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing

Addressing epidemic of opioid addiction

  • Limit unnecessary exposure to opioids, especially in young children
  • Taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products
  • Guidances for Health care professionals and Parents and caregivers

List of Prescription Cough and Cold Medicines Containing Codeine

Active Ingredient(s)

Brand Name(s)

codeine, chlorpheniramine

Tuxarin ER, Tuzistra XR

codeine, phenylephrine, promethazine

Only generics available

codeine, promethazine

Only generics available

codeine, pseudoephedrine, tripolidine

Triacin C

List of Prescription Cough and Cold Medicines Containing Hydrocodone

Active Ingredient(s)

Brand Name(s)

hydrocodone, guaifenesin

FlowTuss, Obredon

hydrocodone, pseudoephedrine, guaifenesin

Hycofenix, Rezira

hydrocodone, chlorpheniramine

Tussionex Pennkinetic, Vituz

hydrocodone, chlorpheniramine, pseudoephedrine


hydrocodone, homatropine

Only generics available


Image credits: FDA


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