High Priority - Business or Marketing Mode Concept. 3D

FDA Prioritizes ANDA for Valsartan to Avert Shortage

On March 12, 2019, the FDA approved an ANDA for Valsartan “to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of Valsartan and other ARB medicines contain nitrosamine impurities.”  The Agency prioritized the ANDA’s approval but is it not yet clear how quickly the FDA approved the ANDA or when it was submitted as it is not yet listed on the approval site or in the Orange Book.

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First Time Generic Approvals January to March 8, 2019

Each year, the OGD publishes a list of first-time generic approvals, which are defined by the agency as:

“First generics” are just what they sound like—the first approval by the FDA which permits a manufacturer to market a generic drug product in the United States.  The FDA considers first generics to be important to public health and prioritizes review of these submissions.

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Whoops! February Approval Actions at 99 or 106! But Don’t Be Fooled by the Numbers – Plus January Stat Update

Well, for the first time, our initial estimates of approval actions for a month was higher than the reported official figures, but are they really?  Don’t know exactly how that happened because our estimates are usually below the totals.  Anyway, the official figures posted today (here) were eight-two full approvals and seventeen tentative approvals.  

FDA Issues Guidance Document on CGT

Today, the FDA issued a guidance document titled “Competitive Generic Therapies (CGT)” which describes the new statutory requirements under section 506H of the FDA Reauthorization Act of 2017 (FDARA).  CGT was enacted to promote and incentivize the development, expedite the review (and thus approval) of certain previously approved drugs with little or no competition.  In addition,

OGD Has Another Banner Month on the Approvals Front – But Still No Word on Receipts!

OGD just released its official January approval figures and we nailed it in our previous post here, where it was reported that OGD would have 102 approval actions in January, despite the shutdown.  Well, we actually hit the nail on the head, as OGD did indeed break the 100-approval action mark by fully approving eighty-one ANDAs and tentatively approving twenty-one ANDAs.

FDA 10th Annual Report on 505(q) Petitions and Stay of Action Petitions Released

Required by Section 914 of the Food and Drug Administration Amendments Act of 2007, the annual report of the impact of 505(q) petitions and petitions for stay of action issued this last Thursday.  This report discussed the number of such petition and describes any delays in approval that such petitions may have caused. The report covers FY 2017.

December OGD Stats Updated, but Still No ANDA Submission Data

As we previously reported here and here, December receipts are missing from the update, even though the rest of the December metrics have been updated (see below).  Well, they are not really missing (other than in the report), they just have not been figured out by FDA, due to the issues associated with the shutdown and the inability of FDA to collect user fees during the shutdown period. 

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Are You at the Table, or On the Menu? Shouldn’t That Be an Easy Choice?

The annual meeting of AAM, Access 2019, is being held in the Hyatt Regency, New Orleans from February 4-6, 2019. The agenda of February 4th involved several sessions to be attended only by the members, including that of Science & Regulatory and Policy Working Group, and the Board Meeting.  The Science & Regulatory Team discussed about the future of GDUFA and BSUFA,