While Friday, August 8, 2025 didn’t appear to be different than any other Friday during the summer, it turned out to be a rather momentous date for a few ANDA sponsors. This is because it was the day that the FDA’s Office of Generic Drugs approved three ANDAs for Iron Sucrose Injection as therapeutically equivalent to Venofer Injection.

As many in the generics industry are aware, seeking approval of an ANDA for any injectable iron product can most politely be described as “challenging.” Many of these challenges can be traced to a history of Citizen Petitions (CPs) submitted to the FDA dating back to 2005 (FDA-2005-P-0319) and the FDA’s response to CP FDA-2016-P-1163 issued on May 26, 2021. On August 8th, in conjunction with the issuance of the approvals for ANDAs 208977, 212559, and 212340, the FDA issued a response to CP FDA-2021-P-0893 wherein the Agency reversed its 2021 CP response and reinstated the active ingredient names for each of the drug products that it had changed to ferric oxyhydroxide in May 2021 (see CP response here). The FDA also responded to the 2005 CP on August 8th (here). The FDA’s Orange Book now reflects the active ingredient corresponding to the iron-carbohydrate complex associated with each of the respective RLDs for Venofer, Ferrlecit, INFeD, Dexferrum, Proferdex, and Iron Dextran.

Despite what this author views as a number of rather momentous approvals, I was unable to find any mention of these actions in a press release or any other announcement by the FDA. Presumably, this can be directly attributed to the reductions in staffing, which greatly impacted the communication professionals within the Agency. In the past, a statement from the Director of the Office of Generic Drugs would have been issued to highlight a first or complex approval that had been in review for years. In addition, these approvals are noteworthy because my review of patent and exclusivity listings in the Orange Book indicates that no patents were ever listed for Venofer. Venofer was only protected for various time frames by four periods of market exclusivity: NP, which expired on November 7, 2003; I-474, which expired on October 17, 2008; I-459, which expired on June 17, 2008; and NPP, which expired on September 21, 2015. Thus, for at least the last decade, there have been no patent or exclusivity barriers to approval of ANDAs for Iron Sucrose Injection, and it is highly likely that approvals could have been issued even earlier had the FDA needed to consider carve-outs of the exclusivities that expired in 2008 and 2015.

Congratulations are in order to those ANDA sponsors that received approval last week for persevering through a long review process. I’ll conclude this post by noting that, as an OGD “old-timer,” I distinctly remember ANDAs being submitted for these products in paper format back in the early 2000s, although none of the ANDAs that were approved on August 8th were submissions from twenty years ago. It is also worth noting that these CP responses appear to have been the first endorsed by Dr. George Tidmarsh, CDER’s new Center Director. I wonder whether he was thinking to himself, “Why am I signing a response to a petition that was submitted twenty years ago?”