Drugs

FDA Denies Petition on Eugia Pharma ANDA

FDA has denied a 7/19 petition submitted by Buchanan Ingersoll Rooney asking that the agency:

review the basis for submission of an ANDA by Eugia Pharma Specialties;
determine that the ANDA should have been filed as a 505(b)(2) NDA;
conclude that FDA should have issued a refuse-to-receive letter; and
require Eugia to refile the application as a 505(b)(2) NDA.

The petition involved the drug Makena (hydroxyprogesterone caproate) that is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

As a result of patent infringement litigation involving a Makena autoinjector, the petition raised concerns that the Eugia ANDA does not cover an autoinjector, that the administration of the drug products might differ, and that the indications for use may not be identical.

In its denial letter, FDA says it has publicly acknowledged the existence of the Eugia ANDA but cannot comment on the application’s contents that would risk disclosing information or data that are not available for public disclosure. Also, it says, the petition includes speculative statements derived from information obtained through patent litigation.

“FDA cannot comment on these statements and your conclusions,” the letter says. “However, as with applications generally, FDA intends to review data and information in any hydroxyprogesterone applications as well as other relevant information consistent with the applicable regulatory and statutory requirements.”

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