Category: Fda

Following the U.S. Food and Drug Administration's (FDA) declaration in late 2024 that the national tirzepatide shortage was resolved, a wave of confusion and misinformation has circulated regarding the medication's status. It is crucial to clarify that the FDA is **not removing tirzepatide** from the market; instead, it has ceased the temporary allowance for compounding pharmacies to produce non-FDA-approved versions of the drug. This regulatory shift impacts patients using compounded products, requiring them to transition to the brand-name alternatives, Mounjaro and Zepbound.

Did you know that many popular oral decongestants sold over-the-counter are largely ineffective? Following extensive review, the FDA announced in late 2024 that it is proposing to remove medications containing oral phenylephrine, an ingredient found in numerous cold and allergy products, because it has been proven to be no better than a placebo for nasal congestion.

The initial U.S. approval for certain uses of atropine sulfate was granted in 1960. However, the long and complex history of atropine's medical use and FDA regulation means the answer to the question, "When was atropine FDA approved?" depends on the specific formulation and indication.

According to the U.S. Food and Drug Administration (FDA), an estimated 80% of active pharmaceutical ingredients (APIs) used in the United States are manufactured overseas, making global supply chain transparency critical. Understanding **What does API stand for in FDA?** is essential for comprehending the foundational element of every medication: the active ingredient that produces the drug's intended effects.

In September 2023, a U.S. Food and Drug Administration (FDA) advisory committee unanimously declared oral phenylephrine, a common active ingredient in over-the-counter decongestants, ineffective. This decision, which has led the FDA to propose removing the ingredient's market status, reveals a decades-old issue with a drug many consumers assumed was working. The situation raises an important question: **what drug did the FDA say was ineffective**?