All Neostigmine Methylsulfate Injection marketed products are
considered UNAPPROVED by the FDA, until now …
BLOXIVERZTM is the first only FDA-Approved
Neostigmine Methylsulfate Injection, USP
Unapproved Drugs Initiative
In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)," outlining its enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process.
What Are Unapproved Drugs and Why Are They on the Market?
The original Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress required that new drugs be approved for safety. In 1962, Congress amended the 1938 law to require manufacturers to show that their drug products were effective, as well as safe. As a result, all drugs approved between 1938 and 1962 had to be reviewed again for effectiveness. To be consistent with current regulations and to ensure that all drugs have been shown to be safe and effective, all new drugs are required to have an approved application for continued marketing.
Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval. In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs. This is not correct. Generic drugs have been evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference drug. Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand name drugs. Unapproved drug products have not been evaluated and approved by FDA. Unapproved drugs are not generic medications, and neither their safety nor their efficacy can be assured.
Unapproved Drugs: Drugs Marketed in the United States That Do Not Have
Required FDA Approval.
Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. The FDA's evidence-based system of drug approval and the over-the-counter (OTC) monograph system play essential roles in ensuring that drugs are both safe and effective. For instance, during the drug approval process the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. Furthermore, FDA's review of the applicant's labeling insures that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.
The Agency has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Physicians and other health care practitioners, along with consumers, cannot assume that all marketed drugs have been found by the FDA to be safe and effective. For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the U.S. without required FDA approval. The manufacturers of unapproved drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern.
To learn more about the FDA initiative to remove unapproved drugs from the market, please click on the following link: