Today, the FDA is warning consumers of potentially contaminated copycat eye drops that are unapproved new drugs that “copy the Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief.” While the FDA notes that it has not received any specific reports of adverse events with the three products named below, […]
As a proud Silver Sponsor of this important conference, we’ll be looking for you at Access! 2024. This annual meeting of the Association for Accessible Medicines (AAM) is happening in Tampa, Florida at the JW Marriott from Monday, February 5th through Wednesday, February 7th, 2024. Visit with us at Booth #11. The Lachman Consultants team […]
This morning, when I read a Decision and Order issued by the United States Court of Federal Claims regarding a motion that was granted in part, denied in part, and filed on behalf of a pharmaceutical company and the FDA, the hair on the back of my neck stood on end. Now, I must state […]
Marty Shimer, Executive Director at Lachman Consultants, wrote a great post (here) about ANDA suitability petitions and the new GDUFA goal dates being assigned to them. His post gives us hope that the new system in place will provide some meaningful timelines for actions on ANDA suitability petitions used to make certain permissible changes from […]
Well, after a somewhat underwhelming start to FY 2024 (which began in October 2023), as reported here, it looks like things are picking up on the approval front for ANDAs. With approval postings through January 17th available today, the OGD has issued thirty-two full-approval actions and ten tentative-approval actions. This should bode well for a better January […]
Yesterday, the Office of Generic Drugs published the November addition to its FY 2024 Generic Drugs Program Monthly and Quarterly Activities Report (here). Officially, the OGD issued 51 final ANDA approval actions and 17 tentative-approval actions for a total of 68 approval actions. Of the 51 final approval actions, four were for first-time generics and six […]
Some of the big-ticket items mentioned in the FY 2023 report are Office of Compliance (OC) actions taken regarding the “contamination from diethylene glycol and ethylene glycol (DEG/EG), potentially harmful eye products, and mitigating risks from drug shortages while ensuring the safety our drug supply.” These issues caused the OC to “pivot” from its business as […]
Back in August 2023, we reported the approval of a significant number of Lisdexamfetamine ANDAs (here) that we believed would mitigate the ongoing shortage. Today, however, the FDA reported (here) that Lisdexamfetamine capsule dosage-form products are in trouble again. On the list of Lisdexamfetamine Dimesylate Capsule drug shortages are eleven companies, with only two of […]
Are the wheels coming off the plan to import drugs from Canada, just days after FDA approved Florida’s import plan? It appears that Canada is not too happy and will take any action necessary to assure that importation of drugs by one of the biggest states in the United States will not disrupt the Canadian […]
The FDA report Advancing Health Through Innovation: New Drug Therapy Approvals 2023 (here) outlines the progress that the Agency has made on the approval of novel drugs (those “which are for therapies that have not previously been approved in the U.S.”), and provides a number of interesting statistics, so I urge you to read the […]
