Regulatory Roundup: FDA Issues Warning Letters to Eight Companies for OTC Drugs, More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, USP signed a Memorandum of Understanding with the Permanent Commission of the Pharmacopeia of the United Mexican States, more...

The US Food and Drug Administration issued Warning Letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain-reliever ibuprofen, according to an Aug. 20, 2009 release. The agency allows some OTC drugs to be marketed without  first obtaining approval through a new drug application (NDA),  but such products must comply with applicable monographs. Because there is no OTC ibuprofen monograph, companies marketing these drugs must submit an NDA. The products and companies receiving Warning Letters are: Emuprofen (Progressive Emu), BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories), Ibunex Topical Ibuprofen (Core Products International), LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products), IB-RELIEF (MEKT LLC), Profen HP (Ridge Medical Products) IbuPRO-10 Plus, (Meditrend,dba Progena ProfessionalFormulations), andIBU-RELIEF 12 (Wonder Laboratories).


Health Canada stated in Aug. 20, 2009 media advisory that it is working with manufacturers to further strengthen product labeling for tumor necrosis factor (TNF) blockers. These particular blockers, used to treat chronic inflammatory diseases, can increase the risk of certain cancers in children and young adults, according to the advisory. The revised labeling requirements will ask manufacturers to note the risk of specific types of cancers that can affect younger patient groups when taking these products. FDA took similar action in early August.



The Philippine government signed a law to strengthen its food and drug administration, according to an Aug. 18, 2009, release from the Office of President Gloria Macapagal-Arroyo. The Republic Act 9711, also known as the Food and Drugs Administration (FDA) Act of 2009, officially renamed the country’s Bureau of Food and Drugs to the Food and Drug Administration and strengthened the agency’s authority. Increased authority under the Act will allow the Philippines’ FDA to “order the ban, recall and withdrawal of health products that cause or has the potential to cause death, serious illness or injury to people,” according to the release. “It can also do the same to products that make deceptive claims.”


The World Health Organization said that orders for the H1N1 vaccine have topped one billion, according to an Agence France-Pressereport. For some countries, such as Germany, the United States, Britain, and France, shortages could be a concern because the orders placed would cover roughly 30–78% of the population, according to the report. Other countries such as Greece, The Netherlands, Canada, and Israel, ordered enough of the vaccine to treat their entire populations. "In the early days, there will be a very limited supply of vaccine. There won't be sufficient supply to vaccinate whole populations, or even huge proportions of populations," WHO spokeswoman Melinda Henry told AFP.


The United States Pharmacopeial (USP) Convention signed a Memorandum ofUnderstanding (MOU) with the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM) to collaborate on the development of standards for medicines. The MOU allows for the revising, updating, and integrating monographs for medicines contained in both pharmacopeias; exchanging scientific and technical information though meetings, courses, and conferences; and establishing joint reference materials.