Accutane/Sotret: An anti-acne medication. The FDA approved Roche’s brand-name Accutane in 1982. In 2002, the FDA approved a version called Sotret, made by Ranbaxy Laboratories. The active ingredient is isotretinoin.
AIP: Application Integrity Policy. A sanction imposed by the FDA when it suspects fraud in a company’s applications. Under an AIP, the FDA will stop reviewing a company’s pending applications until a company can prove the accuracy of its data.
ANDA: Abbreviated New Drug Application. An application compiled by a generic drug company and submitted to the FDA to request approval of a generic drug. An ANDA is known in industry parlance as a “jacket.”
API: The active pharmaceutical ingredient is the biologically active component of a drug. This is the most important, and often most expensive, ingredient in a finished drug.
AUC: The area under the curve, as charted in a graph. The AUC reflects the total concentration of a drug in the blood of a patient over time.
bioequivalence: A standard the FDA uses to determine whether a generic drug works similarly in the body to the brand-name version. According to the FDA’s statistical formula, a generic drug’s concentration in the blood should not fall below 80 percent or rise above 125 percent of the brand-name concentration, using a 90 percent confidence interval.
brand-name drug: A drug that is discovered and developed by a pharmaceutical company, and typically protected by a patent. Manufacturers of brand-name drugs are sometimes referred to as innovator companies.
bulk drugs: The primary ingredients used in making active pharmaceutical ingredients or finished drugs.
CDER: The Center for Drug Evaluation and Research. A branch of the FDA that regulates brand-name and generic drugs by reviewing new drug applications and monitoring the safety of drugs after they are approved.
cGMP: Current good manufacturing practices, as outlined in Title 21 of the Code of Federal Regulations, lay out the FDA’s expectation of how manufacturing facilities should operate.
chromatogram: A graph that is often produced using an HPLC machine, displaying the results from separating the components of a drug sample.
Coreg/carvedilol: A medication used to treat high blood pressure and heart failure. The FDA approved brand-name Coreg, made by GlaxoSmithKline, in 1997. Subsequent generic versions are known by the drug’s active ingredient, carvedilol.
Demadex/torsemide: A medication used to treat fluid retention for patients with congestive heart failure. The FDA approved Roche’s brand-name Demadex in 1993. Generic versions are named for the drug’s active ingredient, torsemide.
excipients: The inactive ingredients in a drug that may include coloring agents, preservatives, and fillers.
FDA: The U.S. Food and Drug Administration. The FDA is the federal agency that regulates the safety and quality of the nation’s food, medicine, and medical devices.
FDA investigator: An FDA employee trained to inspect manufacturing facilities. Investigators are also sometimes referred to as “inspectors” or “consumer safety officers.”
Form 483: When an FDA investigator uncovers violations of current good manufacturing practices during an inspection at a manufacturing facility, those findings are recorded in a form called a 483.
furosemide: A generic drug used to treat fluid retention in patients with congestive heart failure. The brand-name version, Lasix, was first approved for use in the 1960s.
gabapentin: An antiseizure medication named for the drug’s active ingredient, gabapentin. The brand-name drug Neurontin, made by Pfizer, was approved in 1993.
generic drug: Medicine manufactured to work similarly in the body as a brand-name drug, typically sold after the original drug’s patent expires. To be approved as bioequivalent, a generic drug must have the same “dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use” as a brand-name drug, according to the FDA.
heparin: An anticoagulant drug used to prevent blood clotting.
HPLC: High performance liquid chromatography. A common technique used to separate out and quantify components within a drug sample. Drug manufacturers use HPLC machines to identify and measure impurities in a drug.
import alert: A public announcement issued by the FDA to its field staff to detain shipments of products deemed unsafe at ports of entry. Import alerts can be issued for specific types of products or for products from specific manufacturing plants.
Lipitor/atorvastatin: A medication that helps lower cholesterol. The FDA approved Pfizer’s brand-name Lipitor in 1996, and later approved Ranbaxy’s generic version, atorvastatin, named for the active ingredient atorvastatin calcium.
NAI: No Action Indicated. One of three designations FDA investigators use to rank a facility after inspection. NAI means the investigator did not observe deviations from current good manufacturing practices and the facility does not need to take corrective action.
OAI: Official Action Indicated. One of three designations FDA investigators use to rank a facility after inspection. OAI means the investigator observed significant deviations from current good manufacturing practices and has recommended the facility take prompt corrective action or face further regulatory consequences.
PEPFAR: The President’s Emergency Plan for AIDS Relief, launched by President George W. Bush in 2003. The program, ongoing today, funds the purchase of low-cost generic drugs and provides them to AIDS patients in Africa and elsewhere.
Pravachol/pravastatin: A medication used to lower cholesterol. The FDA approved Bristol-Myers Squibb’s Pravachol in 1991. Generic versions are named for the drug’s active ingredient, pravastatin sodium.
Prograf/tacrolimus: A medication that suppresses the immune system to prevent organ rejection in transplant patients. The FDA approved Astellas’ brand-name version, Prograf, in 1994. Generic versions are named after the drug’s active ingredient, tacrolimus.
SAR: The Self-Assessment Report. A confidential document compiled inside Ranbaxy Laboratories in 2004 that details extensive data fraud at the company.
substandard drug: A drug that does not meet quality standards set by the FDA or other established regulatory authorities.
Toprol XL/metoprolol succinate extended-release: A long-acting beta-blocker used to treat chest pain and high blood pressure. The FDA approved AstraZeneca’s brand-name Toprol XL in 1992. Subsequent generic versions are named after its active ingredient, metoprolol succinate.
USP: The United States Pharmacopeia. An independent nonprofit organization that establishes and reconciles global standards for how prescription drugs are made.
VAI: Voluntary Action Indicated. One of three designations FDA investigators use to rank a facility after inspection. VAI means the investigator observed some deviations from current good manufacturing practices and recommends the facility make voluntary corrections.
warning letter: This official message from the FDA warns a company that its facility has violated FDA regulations and must promptly address the issues detailed in the letter or face additional enforcement actions.
Wellbutrin XL/Budeprion XL: A long-acting medication used to treat depression. The FDA first approved GlaxoSmithKline’s brand-name Wellbutrin XL in 1985, and later approved Teva’s generic version, Budeprion XL. The drug’s active ingredient is bupropion hydrochloride.