he newly posted and updated Paragraph IV list, which provides the date that the first ANDA with a patent challenge was received by the FDA, has four very interesting listings, all of which make it clear that generic firms are not letting the moss grow under their feet.
Today, the Activities Report of the Generic Drug Program 2015 received its first update since March 2015. However, it was only a partial update, as no information relative to amendments received for original or supplemental applications were posted.
There are numerous FDA-approved combination cough syrups on the market. In addition, Codeine with Guaifenesin is an OTC monograph product that can be sold without prescription in many states. The use of these products in pediatric patients (under 18 years of age) can cause breathing and respiratory problems.
June 2015 saw the largest number of approvals in a single month since the start of GDUFA, at 57 full approvals and 10 tentative approvals, while receipts were a meager 37. This reverses a long trend of receipts outpacing approvals and represents a month where the backlog actually has an absolute decrease of at least 30 applications.
With the first quarter of GDUFA 2015 and metrics behind us, we are seeing what FY 2015 may have in store for us, and importantly, we have observed that (at least right now) you cannot always believe all of the numbers you see.
For years, FDA has been indicating that it was planning to take enforcement action against certain marketed unapproved prescription and OTC ear drops, but, yesterday, the final shoe dropped on the marketing of such products, as FDA published its intent to take enforcement action against these products in a Federal Register notice (here). The FDA […]
FDA first released its guidance on Controlled Correspondence Related to Generic Drug Development in August 2014. We previously blogged about this guidance (here). In today’s Federal Register notices, FDA provided its response to comments received on the Guidance document.
In the latest salvo fired over the controversial FDA proposed rule that would permit generic drug ANDA holders to unilaterally change their drug product warnings, Senator Lamar Alexander, Ranking Member, Committee on Health, Education, Labor & Pensions and Congressman, and Bob Goodlatte, Chairman of the Judiciary Committee asked the Office of Management and Budget’s Administrator of the Office of Information and Regulatory Affairs (OIRA) to explain a few things about the FDA position.
The buzz about abuse-deterrent opioids (no pun intended) in some camps seems to view these products as a panacea for the prescription drug abuse problem. In my view, that is far from the reality of the problem and clearly miles from the solution.
In response to stakeholder requests, the FDA has delayed the enforcement date only for dispensers under the Drug Supply Chain Security Act (DSCSA) until November 1, 2015.
