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.  

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Commissioner Gottlieb Resigns – A Blow to the FDA and the Health of the Nation

In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation.  Dr. Gottlieb will stay in his position for about a month.  There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his taxing weekly commute to Bethesda/D.C.

Continuous Manufacturing Guidance Issued by FDA – Can Generics Successfully Implement this Strategy?

Today, the FDA issued a guidance titled Quality Considerations for Continuous Manufacturing (here).  Talk about a controversial proposition!  The generic industry has long held that implementation of continuous manufacturing might not be appropriate for their business.  Why?  I am not always clear on the answer to that question, but change is always difficult,

BE Guidances Flying Off the Shelf – The Revisions Can Hit the Floor the Hardest!

Today, the FDA issued twenty-two new bioequivalence recommendations, some of which were for some fairly old products, including a couple of DESI drugs.  There were no surprises in the newly issued listings; however, as we have gone on about previously, the FDA has also issued fifty-two – yes, fifty-two – revisions to previously issued guidances. 

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,

New OGD Director Named!

Today, the FDA announced the appointment of Sally Choe, PhD to succeed Kathleen (Cook) Uhl, M.D. as Director of the Office of Generic Drugs (Cook’s last day at OGD will be March 2).  Dr. Choe currently serves as Deputy Office Director, Office of Study Integrity and Surveillance within Office of Medical Products and Tobacco, Center for Drug Evaluation and Research,

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.