40-44 FDA Taking Comments on “First Generic” ANDA Process

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FDA Taking Comments on “First Generic” ANDA Process

FDA has opened a public docket and is requesting comments on proposed criteria for “first generic” abbreviated new drug application submissions.

The purpose is to facilitate FDA’s establishment of review prioritization under the Generic Drug User Fee Amendments of 2012.

Establishing clear criteria for this review prioritization category will allow the agency to appropriately prioritize and track ANDA submissions.

Clear criteria for this category will also lead to less industry confusion and more consistent identification of first generic submissions, the agency said.

FDA is requesting comments and supporting information on the following criteria—a first generic application is any received ANDA:

(1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and

(2) for which there is no previously-approved ANDA for the drug product.

FDA believes that these proposed criteria appropriately focus FDA’s resources on approving as quickly as possible, new safe and effective generic drug products for patient use.

The agency said these criteria enable it to prioritize review of apendingANDA when the date on which the ANDA can be approved alters due to changes in the patent or exclusivity landscape.

Under these proposed criteria, first generic status is predicated largely on circumstances outside agency control, and ones that may change while the ANDA is pending, for example, developments related to the disposition of related patent litigation.

FDA also is seeking comments and supporting information on mechanisms the agency could put in place to facilitate ANDA sponsor submission of such relevant information in a timely manner, in addition to that already required under the regulations.

As a result of such developments, ANDA submissions that originally met the criteria for a first generic submission may no longer meet those criteria, the agency said. For example, the validity of a patent may be upheld in litigation, thereby blocking approval until patent expiration.

The agency is therefore seeking comment on whether it should change the review prioritization for an ANDA that no longer meets the first generic criteria during its review.

Comments must be submitted by Dec. 19. Electronic comments can be submitted to the federal eRulemaking Portal: http://www.regulations.gov.

FDA granted a Fast Track designation to MM-398 (nanoliposomal irinotecan injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

Fast Track is designed by the FDA to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.

Merrimack is currently preparing a New Drug Application for the indication. Fast Track designation allows sections of the NDA to be submitted to the FDA as they are completed.

According to Merrimack, the company expects to initiate the NDA submission in 2014 with the goal of completing the NDA submission late in the first quarter or early in the second quarter of 2015.

FDA and the European Medicines Agency have granted MM-398 orphan drug designation in metastatic pancreatic cancer.

MM-398 is a nanoliposomal encapsulation of the chemotherapeutic irinotecan. MM-398 has demonstrated extended circulation in comparison to free irinotecan in the clinical setting. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I and promoting cell death.

FDA granted Orphan Drug Designation to the JCAR015 chimeric antigen receptor product candidate, developed by Juno Therapeutics Inc., for the treatment of acute lymphoblastic leukemia. Phase I trials are currently underway at Memorial Sloan Kettering Cancer Center, Juno’s collaboration partner.

All three of Juno’s CAR T cell product candidates currently in trial, including JCAR015, are based on chimeric antigen receptor technology that employs the body’s immune system to attack cancer cells.

JCAR017, in phase I/II trials at Seattle Children’s Hospital, is being tested for pediatric and young adult relapsed/refractory CD19 positive leukemia.

JCAR014, currently in phase I/II trials at the Fred Hutchison Cancer Research Center, is being tested for relapsed or refractory chronic lymphocytic leukemia, non-Hodgkin’s lymphoma, and acute lymphoblastic leukemia.


President Joe Biden’s proposed Advanced Research Projects Agency-Health would be a welcome partner to NCI—particularly in conducting large, collaborative clinical investigations, NCI Director Ned Sharpless said.“I think having ARPA-H as part of the NIH is good for the NCI,” Sharpless said April 11 in his remarks at the annual meeting of the American Association for Cancer Research. “How this would fit with the ongoing efforts in cancer at the NCI is still something to work out.”