-
Jan 18, 2025 | 
saludequitativa.blogspot.com | Sara W. Koblitz
-
Jan 15, 2025 | 
thefdalawblog.com | Sara W. Koblitz
On January 7, 2025, FDA that back on November 12, 2024, the Center for Veterinary Medicine (“CVM”) issued Warning Letters to six online retailers marketing unapproved new animal drug products that purported to treat and control seizures and epilepsy in dogs and cats. At minimum, this autumnal burst of Warning Letters from CVM is notable because CVM only issued a total of 22 Warning Letters in 2024—at least that have been made public by the Agency.
-
Jan 14, 2025 | 
mondaq.com | Sara W. Koblitz
Whether a patent can be listed in the Orange Book is a criticalissue for both brand and generic manufacturers, and, of particularinterest in the last few years is whether patents claiming just thedevice constituent of a combination product is eligible forlisting. While mums the word from FDA, the FTC has some strong opinions on the issue. Andboth the First Circuit and the District Court for New Jersey have weighed in.
-
Jan 8, 2025 | 
mondaq.com | Sara W. Koblitz
Since the induced infringement finding in GSK v. Teva,the generic industry has feared the death of the skinny label(admittedly stoked by alarmist headlines like my own, seeDing Dong is the Skinny Label (Effectively)Dead?).
-
Jan 8, 2025 | 
thefdalawblog.com | Sara W. Koblitz
Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing. While mums the word from FDA, the FTC has some strong opinions on the issue. And both the First Circuit and the District Court for New Jersey have weighed in.
-
Nov 10, 2024 | 
mondaq.com | Sara W. Koblitz
The fight between Jazz, Avadel, and FDA over narcolepsy drug
sodium oxybate has been a long and arduous one. Starting in 2022 with a patent certification requirement,
both Jazz and Avadel have sued FDA over this drug, with Jazz most
recently bringing suit challenging FDA's decision that
Avadel's Lumryz (sodium oxybate) is clinically superior to
Jazz's Xywav (sodium oxybate) in 2023.
-
Nov 7, 2024 | 
saludequitativa.blogspot.com | Sara W. Koblitz
-
Nov 6, 2024 | 
thefdalawblog.com | Sara W. Koblitz
The fight between Jazz, Avadel, and FDA over narcolepsy drug sodium oxybate has been a long and arduous one. Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023.
-
Nov 4, 2024 | 
thefdalawblog.com | Karla Palmer |John W.M. Claud |Sara W. Koblitz
As we reported back in January, Phibro Animal Health Corporation challenged FDA’s decision to remove a drug called carbadox—used as an antimicrobial drug to treat gastrointestinal disease in food-producing pigs—from the market. More specifically, FDA rescinded approval of a “regulatory method” that Phibro used to establish that carbadox is safe and effective.
-
Nov 3, 2024 | 
thefdalawblog.com | Sara W. Koblitz |JP Ellison |John W.M. Claud
Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight to what might have previously been thought of as fairly non-descript Federal agency functions. One of those cases was Loper Bright v. Raimondo, which formally overruled the 40-year precedent under Chevron, under which courts gave agencies deference when interpreting statutory ambiguity.
