Sanofi's third-generation antihistaminic Allegra Tab 120 mg (fexofenadine hydrochloride) has been suspended from advertising for two months.
The Ministry of Food and Drug Safety issued a two-month advertising suspension for Allegra Tab on June 23. The suspension period is from June 27 to Aug. 26.
Handok, the domestic licensee of Allegra, was named as the target of this administrative penalty. Handok holds the domestic distribution rights for Allegra. However, Handok denies any involvement in the case.
The ministry said that Allegra advertisements were carried from around September 2022 to February last year, with content other than approved by a related organization. The underlying laws are Article 68, Paragraph 2 of the Pharmaceutical Affairs Act, and Article 76 of the same act.
Allegra, an over-the-counter drug, is subject to prior review by the Korea Pharmaceutical and Biopharma Manufacturers Association (KPBMA) delegated by the food and drug safety minister.
Sanofi admitted negligence but denied that it was overly advertised.
"While reviewing the advertisement, some details were omitted," a Sanofi official said. "The advertisement did not contain any information different from facts. We are suspending advertising for the first half of the year."
Sanofi launched Allegra 120mg in Korea in February last year. It is licensed as an OTC drug that can be purchased at pharmacies.