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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.

The first report of the year was issued on March 8, 2019 and covered those first generics approved through March 8, 2019.  A curious reporting period but, nevertheless, the OGD had approved sixteen first generics during this time.  The FDA does warn that even though the products may have received FDA approvals, firms may not yet be ready to market them for any number of reasons, which could include patent litigation, a patent or exclusivity settlement agreement, the completion of process validation, or any one of a number of other reasons.  The list of sixteen products can be found here.

Included among them are products to treat symptoms of myasthenia gravis, certain corneal ulcers, depression, iron overload from transfusions, for asthma (the big one this period was for a generic of Advair Diskus), and treat refractory complex partial seizures (CPS), among others.

Two of the sixteen products were for the same drug but different strengths, and five of the sixteen were for the same drug but from different companies approved on the same day.

There were ninety-nine first-time generics approved in calendar year 2018, eighty in 2017, and seventy‑three in 2016.  We will continue to track this report and provide updates as they become available.