Table 1 Brief history of guaifenesin and its regulatory path in the US
From: Role of guaifenesin in the management of chronic bronchitis and upper respiratory tract infections
Time | Key events |
|---|---|
Pre-1500s | Used as natural remedy by Native Americans |
1500s | Guaiac extract used as stimulant remedies, e.g. for sore throat, syphilis |
1800s | Guaiac extract used to treat respiratory diseases in Europe |
1952 | First accepted by US Food and Drug Administration (FDA) |
1989 | Guaifenesin was reclassified to Category I (generally recognized as safe and effective) and was included in the Final Monograph (Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use, 21 CFR 341) as an expectorant for the symptomatic treatment of colds and stable chronic bronchitis. |
2002 | 12-h extended-release (ER) guaifenesin bi-layer tablets were approved by the FDA. From 2007, the FDA removed all marketed, but unapproved, timed-release guaifenesin products from the market. |