For those of us in the regulated industry, we rely on FDA’s website for many different things. FDA.gov has historically been not the most intuitive website, with all of the Centers running their own pages, and inconsistencies occurring as a result of having many “chefs in the kitchen”, as the saying goes. On April 26, […]
In an interesting twist, a firm petitioned the FDA/DEA to request that a synthetic version of Cannabidiol (CBD) oil be placed in Schedule V of the Controlled Substances Act in order for the firm to submit an ANDA for a generic version of Epidiolex (a treatment for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome) […]
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 […]
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. FDA considers […]
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 […]
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 […]
On Friday May 10, the FDA published the much-anticipated final version of the guidance document Considerations in Demonstrating Interchangeability with a Reference Product. We did a general post here and, while recognizing the final version is similar (highly similar?) to the previous draft from January 2017, a careful review (as outlined here) found several useful […]
The issue of the use of biosimilars and their uptake in the market has been a discussion point since the first biosimilar was approved in 2015. Today, the FDA issued a long-awaited guidance on how a firm can demonstrate interchangeability of a biosimilar to its reference licensed product. The guidance is titled Considerations in Demonstrating […]
Today, FDA finalized a guidance document (initially issued in draft in October 2017)that discusses how to best determine if your proposed product should be submitted as an ANDA (505(j)) or an NDA (505(b)(2)). We first blogged about this here. The selection of the type of application to submit has been a source of discussion ever […]
The FDA released a draft guidance today titled Submitting Documents Using Real-World Data and Real‑World Evidence to FDA for Drugs and Biologics (here) that describes how the Agency will receive Real World Data (RWD) and Real World Evidence (RWE) and the potential use of each. After reading the draft guidance, it seems to me that […]
