USFDA

The U.S. Food and Drug Administration approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.

Advancing better nutrition is one of my top priorities and implementing the update to the iconic Nutrition Facts label — the first overhaul in 20 years — is a key part of that commitment.

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The practice of compounding medicines can provide important public health opportunities. The FDA’s compounding program – including implementation of the compounding provisions of the law – is a priority for the agency.

Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and make sure consumers continued to receive safe and effective drug products.

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

U.S. Food and Drug Administration announced its new export certification program for certain FDA-regulated food products and fees it will assess for issuing new export certifications to U.S.-based manufacturers or exporters of these products. Export certification under the Federal Food, Drug & Cosmetic Act (FD&C Act) provides U.S. exporters another tool to facilitate exports to countries that import food products from the U.S.

This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products.

Ensuring that food is safe and truthfully labeled is one of our fundamental responsibilities at the U.S. Food and Drug Administration. Consumers deserve accurate information about the food they eat and how it can affect their health and nutrition. That’s why Congress entrusted the FDA to serve as the nation’s expert on food safety and labeling and to craft predictable, uniform federal requirements on matters within our jurisdiction. Consistent with that authority, we work to provide the best advice possible to Americans about the foods they eat based on the most recent scientific information, taking into account the food’s benefits in addition to any potential health risks.

The U.S. Food and Drug Administration announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.