Tag: Hatch-Waxman Act

Jun, 26 2026
Who Actually Makes Authorized Generics? The Truth Behind the Label

Who Actually Makes Authorized Generics? The Truth Behind the Label

Discover who actually manufactures authorized generics. Learn how brand-name companies use their own facilities or subsidiaries to produce lower-priced versions of their drugs, ensuring quality while competing with traditional generics.

Read More
May, 10 2026
FDA Safety Alerts: How Generic Drug Warnings Work and What to Watch For

FDA Safety Alerts: How Generic Drug Warnings Work and What to Watch For

Discover how FDA safety alerts apply to generic drugs, including labeling gaps, the Hatch-Waxman Act, and the ongoing debate over CBE supplements for faster warning updates.

Read More
May, 10 2026
FDA Safety Alerts Explained: Generic Drug Risks, Labeling Gaps, and What You Need to Know

FDA Safety Alerts Explained: Generic Drug Risks, Labeling Gaps, and What You Need to Know

Explore how FDA safety alerts handle generic drug problems, the labeling gaps caused by the Hatch-Waxman Act, and what patients can do to stay safe with MedWatch.

Read More
Jan, 17 2026
Orange Book Database: FDA's Approved Drug Products With Therapeutic Equivalence Evaluations

Orange Book Database: FDA's Approved Drug Products With Therapeutic Equivalence Evaluations

The FDA's Orange Book lists approved drugs and their generic equivalents, showing which ones can be safely substituted. It's the key to understanding patent expirations, exclusivity, and how generics enter the market.

Read More