FDA Publishes Proposed Rule to Revise the Requirements for Combination and Co-Packaged Rx and OTC Products

In what appears to be an effort for FDA to harmonize their treatment of combination or co-packaged prescription or over-the-counter drug products, the Agency has published a 70 page Federal Register Notice addressing this issue.

The proposed rule notes that “[U]nder proposed § 300.53, two or more active ingredients may be combined in a fixed-combination or co-packaged drug or included as a combination in an OTC monograph when two requirements are met.”


Here’s a Good Idea – Give Congress the Authority to Override FDA Decisions – NOT!

Zachary Brennan of RAPS wrote a nice explanatory piece about a new bill introduced by Senator Ted Cruz (R-TX) and Senator Mike Lee (R-UT) called the RESULT Act, which stands for “Reciprocity Ensures Streamlined Use of Lifesaving Treatments” Act (S. 2388). In effect, the Act would permit reciprocal approvals by FDA for drugs approved in a certain list of countries. In addition, the bill would give Congress the authority to override certain non-approval decisions by FDA for drugs for life-threatening conditions and require FDA to make decisions on such drugs to treat life-threatening conditions in 30 days.

CDER New Drug Review Update 2015

FDA released a presentation by John Jenkins, M.D., Director, Office of New Drugs at CDER.  The report is rather astounding and signals that the PDUFA program and the way FDA approached drug approval is not only collaborative but also thorough.  One rather amazing piece of information is the first action approval rates for FY 2015. 

Vistogard Can Be a Life Saver

The FDA approved Vistogard (uridine triacetate) as an emergency treatment for patient having severe toxic reactions or receiving an unintentional overdose of either fluorouracil or capecitabine. The treatment is a breakthrough for these patients and can be a life saver and/or permit earlier reintroduction of necessary chemotherapy.

The Color of Money – Green, Always Green

We have read a lot about the significant rising cost of some generic drug products, some shortage products, and some old products without competition, even though any period of patent or exclusivity has expired. The entire issue of pricing appears to be focused on a handful of drug products. We certainly don’t want to see the system keep patients from getting the drugs they desperately need and we don’t want to break the bank of private pay patients, insurers, and local, state, and federal governments. So there needs to be a balance. How do we achieve that balance?

ANDAs Received in November 2015 Totaled 43

As we previously reported (here), OGD approved 61 ANDAs and Tentatively Approved 6 ANDAs in November; thus there was appositive reduction of 24 applications in the theoretical backlog. This is (somewhat) the good news and the bad news. The good news is that OGD should have substantive excess review resources available, based on a reduced number of applications received. The bad news is-you are going to pay more for fewer applications.

November ANDA Approval Statistics


November was a good month for full approvals, with a total of 61 issued.  There were 6 tentative approvals issued for the month.  While this is a bit of a fall off from the previous few months, the numbers are consistent with an even keel on approvals.  The hopeful goal for now is to begin to have the industry response to the many Complete Response Letters,