Marketing authorizations for 9 antimalarial and antiallergic drugs have been suspended, according to a press release from the National Medicines Agency (ANSM). These measures were taken as a precaution, following “reservations on the integrity of the data resulting from the bioequivalence tests carried out in the private research center Semler Research located in Bangalore, India”.
The United States Food and Drug Administration (FDA) and the World Health Organization (WHO) have expressed reservations about the reliability of bioequivalence tests at the private research center Semler Research. The methods used do not comply with “compliance with good clinical practices concerning these bioequivalence studies”. Following these questions, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has initiated a procedure to reassess the benefit / risk ratio of proprietary medicinal products. As a result and pending the decision, the ANSM is suspending the MA for these 9 specialties.
As only three active substances are concerned, the ANSM reminds that there is no risk of “breakage or interruption of treatment to the extent that these drugs are available under other brands”.
Antimalarials affected by the ANSM ban
- ATOVAQUONE / PROGUANIL (SANDOZ), 250 mg / 100 mg, film-coated tablets
- ATOVAQUONE / PROGUANIL (SANDOZ), 62.5 mg / 25 mg CHILDREN, film-coated tablet
- ATOVAQUONE / PROGUANIL (TEVA) 250 mg / 100 mg film-coated tablets
- ATOVAQUONE / PROGUANIL (TEVA) 62.5 mg / 25 mg CHILDREN, film-coated tablet
Antiallergics affected by the ANSM ban
- EBASTINE BIOGARAN 10 mg orodispersible tablet
- EBASTINE BIOGARAN 10 mg film-coated tablets
- EBASTINE MYLAN 10 mg film-coated tablets
- EBASTINE ZENTIVA 10 mg film-coated tablets
- EBASTINE ZENTIVA 10 mg orodispersible tablet
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