FDA Preliminarily Suspends Armenpharm’s ANDA for Chloramphenicol

December 11, 2015

The FDA has taken its first step toward yanking approval for a drug nearly 50 years after its initial approval.

In a letter to Armenia-based Armenpharm, the FDA made a preliminary decision to suspend an abbreviated new drug application the company holds. If the agency’s initial decision to suspend the ANDA is finalized, Armenpharm would be prohibited from marketing the generic eye infection drug chloramphenicol, which was granted its ANDA back in 1967.

According to the letter, the agency concluded that chloramphenicol was withdrawn from sale at an unspecified point “for safety or effectiveness reasons,” thereby putting its ANDA in jeopardy. Under the FD&C, if a drug was withdrawn for either of those reasons, the FDA is required to start the ANDA withdrawal process.

Kurt Karst of the law firm Hyman, Phelps & McNamara said that ANDA withdrawals are virtually unheard of, adding that this is the only case he can recall in the past 15 years.

Read the letter here: www.fdanews.com/12-04-15-Letter.pdf.