While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here) on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2. OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting off FY 2019 with a bang!
I remember in the “old days” back in the 70’s, before most of you may have been born, Primatene Mist containing epinephrine, was a life saver as an OTC medicine for mild asthma. Why did it disappear from pharmacy shelves? Because it contained chlorofluorocarbons (CFCs) as a propellant. As you know, CFCs were banned, and phased out of the market in 2011 in an effort to help protect the ozone layer under the Montreal Convention.
The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here). The notice states that:
Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.
The Fourth Annual Global Regulatory Affairs CMC Conference was held in Philadelphia on October 29‑30, 2018. The conference focused on successful developmental and post-market CMC operations and product lifecycle management tactics, based on better understanding of U.S. and global regulatory requirements for small molecules and biologics.
Talking of life -cycle management, the current draft of ICH Q12 loomed large as the deadline for comment by most regulatory bodies of the world is in December 2018.
Although the Office of Generic Drugs (OGD) has not yet released the official approval numbers for October 2018 (which is the first month of FY 2019, and the first month of GDUFA II), it appears that a new record will be set. OGD approved 101 ANDAs, and tentatively approved 21 ANDAs for a total of 122 approval actions for the month;
Late yesterday, the OGD finalized its 2018 statistical chart in its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance which can be found here. There are some interesting figures and comparisons to previous years that are discussed below.
Let’s look at refuse-to-receive (RTR) actions to start. FY 2018 saw the fewest RTRs since the start of GDUFA.
The FDA announced extended use dates for 72 lots of epinephrine autoinjectors. All of the 72 lots can be used for 2 months past the labeled expiration date, according to stability data supplied by the company and reviewed by the Agency. FDA noted in its announcement (here) that it does not expect or require the product to be relabeled with the revised expiration date,
While the FDA does appear to listen rather intently to comments on its bioequivalence (BE) draft guidances, and will occasionally reopen comment periods, it is still the exception rather than the rule. Today a Federal Register (FR) notice (here) announced another sixty-day comment period during which such comments will be entertained.
If the first half of October is any indication of the approval performance of OGD, then we are off to a good start of FY 2019. The first eleven business days of October 2018 yielded forty-three full approvals and fourteen tentative approvals (TAs), and there are still ten business days left in October. Two big days so far this month were October 12th,
What does 42 minutes mean for Competitive Generic Therapies (CGT) exclusivity – apparently everything, when FDA approved another product 42 minutes before commercial marketing began for the first approved applicant. We don’t know for sure if it was 42 minutes (evidence of first commercial distribution) or actually 5 hours and three minutes (when the first approved applicant for potassium chloride actually notified the FDA of its commercial marketing through the FDA’s electronic gateway) but the time window is really not relevant,
The Office of Generic Drugs (OGD) posted its official numbers for approval actions, receipts and complete response letters in the last hour. The figures, from the Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) show that OGD broke the old record of 763 approvals achieved in FY 2017 by 18 ANDAs,
The DIA Complex Drug-Device Combination Workshop is being held at the Sheraton Silver Spring during October 9‑10, 2018. The first day of the conference dealt with the regulatory aspects of the generic submissions for these kinds of products, and discussions on clinical aspects related to complex generics, with a focus on inhalation products.
The meeting was well-attended,
Today FDA announced finalizations in two guidance documents for transdermal systems (TDS) one relative to skin adhesion studies (here) and one related to skin irritation and sensitization studies (here). The revisions to the previous drafts came after FDA considered a number of industry comments to those drafts.
A quick survey of recent FDA Form 483s shows that firms are struggling to meet FDA expectations for timeliness of stability testing. During the last twelve months, the FDA has issued at least sixteen Form 483s for observations related to the timeliness of stability sample testing.
Neither the current guidance ICH Q1A(R2) “Stability Testing of New Drug Substances and Products” nor the FDA November 2003 Guidance for Industry “Q1A(R2) Stability Testing of New Drug Substances and Products” details the expectations for the timeliness of stability sample testing.
OGD updated its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) on Wednesday, giving us a look at some additional metrics for the month of August.
For all the talk of Refuse-to-Receive (RTR) actions, OGD issued only seven (7) in August. Four (4) were for standard ANDAs and three (3) were for priority ANDAs.