I enjoy eating Chinese food with a group, because I can get a sample from each person’s plate. Such as in 505(b)(2) submissions, you can pick and choose parts of different RLD’s for your submission.
A reader was surprised when I previously commented that a 505(b)(2) submission can have more than one RLD. As long as the information is supprortive of your [...]
Archive for May, 2008
RLD - Born in the USA
Published May 26th, 2008 in 505(b)(2) Issues and Formulation Issues. 0 CommentsYou have a global perspective and drug development program. You want to conduct studies in the US and an international location. You’re going to use an RLD from Big Pharma - you know, the global giants. The RLD bought in the US and Europe looks the same, even has the same marking. But are they same? [...]
Paragraph IV Certifications under 505(b)(2)
Published May 18th, 2008 in 505(b)(2) Issues. 0 CommentsWhat is the difference between a Paragraph IV certification between the 505j (ANDA, generic) and 505(b)(2)? None. The difference is the exclusivity outcome - 505(b)(2) never gets any exclusivity based on patent certification.
In a U.S. drug application, in Module 1, Administrative Documents, you must submit a patent certification, regardless of the submission route, generic or [...]
Biovail joined the increasing list of pharma companies that are downsizing or eliminating their 505(b)(2) development programs. As reported in the Wall Street Journal* Biovail CEO William Wells, in a conference call announcing a change in company focus, said “Focusing on the development of products that primarily provide convenience and compliance benefits is not a [...]
505(b)(2) Orphan Drug Approval with only a BE study?
Published May 11th, 2008 in 505(b)(2) Issues. 0 CommentsA reader recently inquired about Orphan drugs and asked me if I thought an Orphan drug developed under 505(b)(2) could be approved based on just a Phase 1 study - a pharmacokinetic or pharmacodynamic comparison to the RLD.
At first I thought I couldn’t think of an example. Generally, an Orphan drug fulfills an unmet need [...]
Even this holiday is linked to 505(b)(2) activity - at least for me and some of my staff. Dr. Ruth Stevens (Exec. VP and Chief Scientific Officer) , Cindy Phurrough (Dir. Clinical Operations), Stacey Ayres (Sr. Research Associate) and Bill Stoltman (Dir. Regulatory Compliance and QA) and I were together at Duramed on that fateful day May [...]
The 505(b)(2) process is used to obtain approval of an isomer of an already approved racemate. An example is cetirizine. The original product approved (Zyrtec) is a racemate. In May 2007, UCB, Inc. obtained approval for levocetirizine dihydrochloride 5 mg tablets, using the 505(b)(2) process. That approval was based on replicate clinical studies. On 1/28/2008 UCB obtained [...]
According to some observers, the US Patent system is undermining innovation. In KSR International versus Teleflex Inc., the US Supreme Court ruled that patents must be “more than the predictable use of prior art elements according to their established functions” or in my layman’s words, you can’t patent something that should have been obvious. The drug [...]
In our webinar last week on Patent & Marketing Exclusivity we received an interesting question that I would like to pass along to readers of this blog.
Q: If there are two RLDs, one with IP and one without IP, does a Sponsor have to certify against both RLDs?
A: If you reference a RLD, you always [...]
Fospropofol turned down or approved by FDA Advisory Committee?
Published May 14th, 2008 in 505(b)(2) Issues and News Commentary. 0 CommentsMGI Pharma’s Aquavan(R) (fospropofol) is a phosphate prodrug of the anesthetic propofol. Propofol must be administered by an anesthesiologist because of its rapid onset.
The phosphate prodrug’s time to onset is delayed due to the conversion to the active moiety.
A slow onset of sedation would reduce the likelihood of sudden and unexpected general anesthesia. MGI hoped [...]