The FDA approved the first generic of Baloxavir Marboxil tablets 40 mg and 80 mg for Norwich Pharmaceuticals Inc., on June 17, 2026. It is the generic equivalent of Genentech’s Xofulza approved for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 […]
I had the good fortune to attend the FDLI Annual Meeting held on May 6th and 7th. The FDLI Annual Meeting is always a good conference where attendees are able to hear many great updates from the FDA and insights on issues related to our industry. This year was no exception, and the FDA had a […]
On Tuesday, April 7th, the FDA announced that the Office of Generic Drugs had approved multiple first generics for Dapagloflozin Tablets. A quick review of the listings for the product in the Orange Book shows that there were a total of fifteen ANDAs approved on Monday, April 6th, which was the first business day that the FDA […]
The AAM GRx+Biosims meeting recently concluded, and it was great to see so many familiar faces and to meet individuals in person for the first time. This conference always affords attendees opportunities to hear new insights from FDA leadership and catch up with colleagues. I’m sure that attendees all had a favorite session or discussion, […]
On October 3, 2025, FDA announced a new “ANDA prioritization pilot (which) represents a further step FDA is taking to incentivize U.S. generic drug manufacturing and testing. Under this pilot, ANDA applicants who conduct any required bioequivalence testing in the United States and whose products are made in the U.S. using exclusively domestic sources for […]
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 […]
One recurrent issue that keeps arising in our consulting practice is the impact of pediatric exclusivity on the ability of the FDA to approve applications during a pediatric exclusivity period associated with a listed patent. For those sponsors that are not careful, a pediatric exclusivity period (or successive periods of pediatric exclusivity that are associated […]
As many in industry are already aware, suitability petitions began to be subject to review metrics at the beginning of Fiscal Year 2024, which started on October 1, 2023. As a reminder, the GDUFA III Commitment Letter (GIII CL) requires the FDA to review and respond to suitability petitions that have been assigned a goal date within six […]
The holidays are fast approaching and many of us are in a joyful spirit, more prone to giving and charity in alignment with the season. That said, considering the effort that goes into sponsors’ pursuit of ANDA approvals where the sponsor or sponsors may be eligible for 180-day exclusivity, I doubt that anyone in the […]
For those of us that live in areas with seasonal changes, I’m sure everyone has experienced the telltale signs that autumn is right around the corner. These changes are subtle at first but soon gain significance and portend a future that looks different than the present. Individuals who carefully examine the FDA’s Paragraph IV (PIV) Patent […]
