Regulatory Focus™ > News Articles > Court Blasts, Denies ISTA Pharmaceuticals' Challenge to ANDA Filing

Court Blasts, Denies ISTA Pharmaceuticals' Challenge to ANDA Filing

Posted 22 October 2012 | By

The US District Court for Washington, DC has ruled against ISTA Pharmaceuticals Inc. (PDF), which had filed suit against the US Food and Drug Administration (FDA) in a case regarding whether the agency had lawfully approved a generic version of the company's eye-drop drug manufactured by a competitor.

The case, heard and decided by Judge James Gwin, regarded FDA's 2009 approval of Coastal Pharmaceuticals' abbreviated new drug application (ANDA) for a generic version of Xibrom (bromfenac ophthalmic solution)-an older version of a drug now branded as Bromday under a different set of dosing recommendations.

The problem, argued ISTA, was that Coastal was improperly referencing the Xibrom as the reference-listed-drug (RLD) instead of using the current Bromday label, which had received extended marketing exclusivity for a once-a-day labeling change. Xibrom has since been taken off the market, leaving only the once-a-day Bromday formulation available to prescribers.

ISTA further argued that until FDA could determine that Xibrom had been removed from the market for reasons unrelated to safety or efficacy, the agency should withhold granting Coastal's ANDA.

FDA, however, disagreed, and on 11 May 2011 denied ISTA's petition and granted Coastal's ANDA, triggering legal action by ISTA against the agency soon after.

A Strong Rebuke

ISTA's argument boiled down to two points, wrote Gwin: Xibrom's labeling was obsolete once ISTA received the updated labeling for Bromday because it was a single product rather than two separate ones, and because FDA had found the 2.4ml bottle size for Xibrom potentially unsafe, Coastal's ANDA could not proceed without a conclusive determination by FDA regarding its safety.

The court rejected both of these arguments using harsh, unambiguous language. ISTA's argument regarding the "currently approved" labeling for the drug was, "At best, disingenuous-at worst, intentionally misleading," wrote Gwin.

The court said it was particularly perturbed by ISTA's contention that the two products were, in fact, a single product when it had simultaneously marketed both drugs for at least four months under their respective trade names before pulling Xibrom a day before filing its complaint with FDA.

"In this case, ISTA says that Xibrom and Bromday are a single product, and thus, the argument goes, Bromday's label is the only 'currently approved' label," explained Gwin. "But ISTA fails to offer any substantial basis for its contention that Xibrom's label was (and is) not currently approved. The list of arguments, while extensive, is wholly unpersuasive. "

Likewise, Gwin said he was not persuaded by ISTA's argument that FDA had not determined that Xibrom was withdrawn without safety problems. FDA, he said, only approved the generic version, "After making the determination Xibrom-the listed drug-had not been withdrawn from sale for safety or effectiveness reasons."

Gwin denied ISTA's motion for summary judgment and granted FDA's motion for summary judgment. ISTA was acquired by eye care manufacturer Bausch & Lomb in May 2012, and it is not entirely clear whether Bausch will continue ISTA's legal case.


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