Tag: Drug approval

The U.S. Food and Drug Administration (FDA) did not evaluate Voltaren gel for back or shoulder pain, approving it only for smaller, superficial joints. Understanding why you can't put Voltaren gel on your back is crucial for safe and effective pain management, as misuse can increase health risks associated with the active ingredient, diclofenac.

The FDA's Orange Book is updated on a multi-tiered schedule, with certain information being updated daily, while other components are updated monthly, quarterly, or annually. This staggered system ensures that stakeholders in the pharmaceutical industry and the public can access the most current information regarding approved drug products and therapeutic equivalence evaluations.

As of late 2021, the U.S. FDA has approved the first generic version of lanreotide, offering a new alternative to the brand-name drug, Somatuline Depot. The key question, "**Is there a generic for lanreotide?**", now has a definitive "yes" answer, though patients and healthcare providers must consider several factors regarding its use and indications.

First approved by the FDA as a topical ophthalmic medication in 1978, natamycin has a complex regulatory history. To determine whether **is natamycin FDA approved**, one must consider its distinct applications in both medical treatment and food preservation.

While the fast-acting pain relief inhaler Penthrox, known informally as the “green whistle,” is a common sight in emergency and trauma settings across Australia and Europe, the medication is not available for civilian use in the USA. Its absence is rooted in a complicated history with its active ingredient, methoxyflurane, and a formal safety determination made by the US Food and Drug Administration (FDA) nearly two decades ago.

The FDA issues numerous guidance documents annually to help regulated industries, including those in pharmacology, understand the agency's current thinking. A specific type, a Level 2 FDA guidance, is distinguished by its less complex nature, focusing on existing practices and minor policy adjustments.

In 2024, the U.S. Food and Drug Administration (FDA) approved the first-ever drug for Metabolic Dysfunction-Associated Steatohepatitis (MASH), a serious liver disease. A **MASH drug** is a medication specifically designed to treat this condition, which is characterized by fat buildup, inflammation, and scarring in the liver. The approval of these specialized treatments marks a significant advancement for millions affected by this progressive disease, who previously had limited therapeutic options.

Over 1.14 million deaths were attributed to bacterial antimicrobial resistance (AMR) in 2021, underscoring the urgent need for new therapies to address the question, **What is the new FDA approved antibiotic?**. The newest approvals offer targeted weapons against increasingly defiant pathogens, providing critical new options for healthcare professionals.

Since its establishment in 1995, the **European Medicines Agency (EMA)** has been responsible for the scientific evaluation and supervision of medicines across the European Union (EU) and European Economic Area (EEA). This vital regulatory body ensures that all human and veterinary medicines marketed within its jurisdiction meet stringent standards of quality, safety, and efficacy before they are made available to patients.

According to research, inadequately controlled chemotherapy-induced nausea and vomiting (CINV) significantly impacts patient quality of life. In response, pharmaceutical development has been consistently active, leading to several new formulations and novel applications of existing medications. The question of what is the new anti nausea drug is not singular, but points to an evolving landscape of antiemetic options.