Warning Letter Roundup: AstraZeneca Hit for Misleading Breztri Ads, Other Drugmakers Slapped for Selling Unapproved Drugs, GMP Violations
The FDA has reprimanded AstraZeneca for making false and misleading claims about its chronic lung inflammatory inhalation therapy Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate), while the agency has also smacked Denison, CalmCo and ALVA-AMCO Pharmaceutical Companies for selling unapproved drugs and good manufacturing practice (GMP) violations.
Source: Drug Industry Daily