FDA reported 70 full approval actions and 15 tentative approval actions in September for a total of 85 approval actions for the month. The 85 approval actions fell into the second most approval actions in FY 2020 behind only April’s total of 87. The full approval action in September was also the second highest this […]
On June 1, 2020, in Docket FDA-2020-N-1127 and published in the Federal Register, the Agency asked for public comment regarding updating and clarifying the types of patents that could be listed in the Orange Book (here). The document sought comments on two specific issues of continued interest: should patents be submitted to the FDA and […]
Well, in my book, any movement on 505(j)(2)(C) ANDA suitability petitions is welcome news. The pool of pending ANDA suitability petitions is full at FDA and is, by now, becoming very stagnant. There has been little action on 505(j)(2)(C) petitions in the last 10 years. Just last year, out of the blue, we got two […]
This morning, in reading an article from the Pink Sheet written by Sarah Karlin-Smith, I flashed on my blog post from September 24, 2020 (here) discussing the new warning on benzodiazepine products. In this post, I had expressed concern that the abuse-deterrent formulation (ADF) craze of opioid formulations might be creeping in on other products […]
In a pre-publication notice today, FDA announced the FY 2021 fee for the use of a Tropical Disease Priority Review Voucher, Rare Pediatric Disease Priority Review Voucher, or a Material Threat Medical Countermeasure Priority Review Voucher. That fee is $1,360,879 and remember that is to be paid on top of the $2,875,842 applications user fee […]
The end of the FY saw a bump back up to the 80’s for number of total approvals with 73 “line item” full approval actions and 10 tentative approval actions. What the heck is a “line item” approval action, you may ask? Well, we noticed in September (or perhaps we just missed it in previous […]
The Association for Accessible Medicines released its 2020 Generic Drugs and Biosimilars Access and Savings in the U.S. Report (here) yesterday, outlining the savings that these products brought to American consumers in 2019. “In 2019, according to data provided by IQVIA, U.S. savings from generic drugs added up to $313 billion—including $96 billion and $48.5 […]
In a drug safety communication on September 23, 2020 titled FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class (here), the FDA announced changes being made to the boxed warning on all benzodiazepine products. The communication describes the need for the change as follows: “[T]o address the serious risks of abuse, […]
The history of the issue of the ”intended use” regulations goes back to 2015, as explained in this 39-page pre-publication version of the Federal Register Notice (here), and it is quite an interesting read. The main issue surrounds the notion that, if a firm knows its product is being used for a use not in […]
The news is rife with stories about counterfeit drugs, illegal operating on-line pharmacies, on-line pharmacies dispensing sub- or super-potent medicines, some act as virtual opioid pill mills, but the FDA has launched a campaign to help consumers navigate the online pharmacy morass. Released this morning the FDA’s web page (here) asks in its opening line […]
