On May 20, 2019, the Office of Generic Drugs approved 13 ANDAs for Solifenacin, a generic version of the Brand Vesicare.  The drug is used for treatment of overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence.

The approvals came after pediatric exclusivity was granted which “effectively extended” the patent by 180-days on the innovator product (not actually a patent extension,

Today, OGD updated its first generic approvals list (here).  So far this calendar year, OGD reports 43 first generic approvals through April 26, 2019.  The FDA notes:

“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.  

From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week.  The report on price fixing was met with a response to 60 Minutes May 12,

Today, FDA posted the official ANDA approval actions and receipts for April 2019.  While the All Approval list reported 93 full ANDA approval actions and 15 tentative approval actions for ANDAs, when we wrote our first blog estimating the approval actions for April on May 3rd  (here) ,   the official FDA numbers for April reported for approval actions was 98 and tentative approval actions was 18,