ANDRX'S ANDAS PUT ON HOLD BY FDA
The FDA's Florida District office has placed Andrx's pending abbreviated new drug applications (ANDAs) on hold due to manufacturing problems -- a move that could potentially threaten the generic firm's portfolio of previously approved drugs.
For now, the company's existing products seem to be safe, said Merrill Lynch analyst Gregory Gilbert. "However, we (and the company) cannot rule out an eventual impact on current products," he adds in a research note.
The drugmaker's problems stem from a May inspection in which the FDA discovered possible current good manufacturing practice (cGMP) violations at one of Andrx's facilities. At the close of the inspection, the FDA investigator issued Andrx a Form 483 documenting an undisclosed number of observations.
The agency's Florida District office has since placed Andrx on OAI (Official Action Indicated) status, a designation that means regulatory and administrative actions will be recommended against a firm, according to the FDA. As a consequence of being placed on OAI status, all of Andrx's pending ANDAs have been placed on hold, the firm said.
According to Andrx's website, the company is awaiting approval of 35 ANDAs, including applications for generic versions of attention-deficit/hyperactivity disorder drug Concerta (methylphenidate HCl), antidepressant Wellbutrin SR (bupropion HCl) and anti-smoking drug Zyban (bupropion HCl).
The FDA's move could potentially jeopardize Andrx's partnership with Amphastar Pharmaceuticals to jointly launch a generic version of sanofi-aventis' blockbuster blood thinner Lovenox (enoxaparin sodium), which had sales of $2.3 billion in 2004. In May, Andrx signed the agreement under which it agreed to pay $4.5 million for partial marketing rights to generic Lovenox. The FDA has not yet made a final decision on Amphastar's ANDA, nor on the ANDAs submitted by Teva Pharmaceutical and Momenta for their versions of Lovenox.