BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Wednesday, April 15, 2026
See today's BioWorld
Home » FDA’s Orange Book turns 40
To read the full story, subscribe or sign in.

FDA’s Orange Book turns 40

Oct. 16, 2020
By Mari Serebrov
Once upon a time in an age before the Internet, all things digital and even Hatch-Waxman, the FDA worked in its corner of the government approving drugs and therapeutic equivalents with little fanfare or transparency. Its decisions were duly recorded on paper and filed away. With the files located only at the agency, pharmacies across the country were left to wonder about which drugs could be substituted for another. Their recourse was to pick up the phone and pay for a long-distance call to the FDA every time a question arose. To reduce the number of phone calls it was getting, the FDA printed out a list of approved drugs with their equivalents and sent it to the pharmacies. The year was 1980, and the month was October. Going with the season, the FDA slapped an orange paper cover on the listing, giving birth to the Orange Book.
BioWorld Drugs Regulatory FDA

Popular Stories

  • Today's news in brief

    BioWorld
  • MMP inhibitors divulged in Accure Therapeutics patent

    BioWorld Science
    Accure Therapeutics has reported new oligopeptide derivatives acting as matrix metalloproteinase-2 (MMP-2) and MMP-9 inhibitors. As such, they are described as...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for April 14, 2026
  • Cancer cell in the cross-hairs

    Selective CBL-B inhibitor with improved safety profile disclosed

    BioWorld Science
    CBL-B is a RING-type E3 ubiquitin ligase that acts as a negative regulator of T-cell activation, contributing to immune homeostasis by limiting excessive immune...
  • MSD discloses new HCN1/2 blockers

    BioWorld Science
    Merck Sharp & Dohme LLC (MSD) has synthesized new indazole derivatives acting as potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 1...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing