ACTAVIS CITED FOR MAKING UNAPPROVED DRUGS, NOT REPORTING ADVERSE EVENTS
Icelandic generic drugmaker Actavis failed to conduct a follow-up investigation of a fatal adverse event, did not submit required reports on adverse drug experiences (ADEs) to the FDA and "manufactures numerous prescription drug products without approved applications," the agency said in a warning letter to the firm.
"The specific violations noted in this letter are serious and may be symptomatic of underlying problems," the warning letter said. "Several of the observed deficiencies were longstanding, and there is no indication of how or why the lack of compliance was not identified by your firm, and why it was allowed to continue for such an extended period of time."
The letter comes at a time when Actavis is engaged in an escalating bidding war with Barr over control of the Croatian generic drugmaker Pliva, recently submitting a $2.5 billion offer.
The warning letter, issued Aug. 15 and posted to the FDA website Sept. 14, said the company is manufacturing what "appear to be unapproved new drugs introduced into interstate commerce," including: buspirone HCl tablets (5, 10, and 15 mg); carbetapentane tannate and chlorpheniramine tannate tablets (60 mg/5 mg); guaifenesin and pseudoephedrine HCl extended-release tablets (1200 mg/120 mg); hyoscyamine sulfate tablets (0.125 mg); Nicomide tablets; and yohimbine HCl tablets (5.4 mg).
In a press release Actavis issued in response to the warning letter, the company said that these are "older products that are currently being marketed by the group relying on pre-ANDA [abbreviated new drug application] drug approval mechanisms. Management is confident that each of the identified older drugs [is] currently being marketed in accordance with applicable regulations, but is undertaking a full review of these products to address the FDA's concerns."