In announcing the July 24th approval of Baqsimi (glucagon powder for nasal administration) (here) FDA notes that it is the first form of glucagon that can be administered without injection. The product is to be used by a caregiver or we assume someone on the street if the patient is unconscious. The product is a […]
Like many drugs that undergo clinical trials (even larger trials), rare adverse events may not become apparent until well after the drug is in wider use after approval. In addition, as a condition of approval, the FDA often requires a post-approval commitment to further study the drug. Such is the case as described in the […]
In a Federal Register Notice to be published tomorrow (here), the FDA announced GDUFA User Fees that will be in effect for Fiscal Year 2020, which begins on October 1, 2019 and continues through September 30, 2020. There is some good news and some bad news. Here are the application, DMF, and facility fees for FY […]
According to the FDA, OGD approved 11 ANDAs for Pregabalin (a generic for Lyrica), on Friday, July 19, 2019. However, when looking at the Innovator product’s patent and exclusivity awards, the 180-day pediatric exclusivity expired on June 30, 2019. This got my mind working to try to figure out why the 17-day (June 30 fell […]
In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction […]
With just eleven of the twenty-two working days left in July for the OGD to report approval actions, the number of full approval actions stands at twenty-nine and tentative approval actions sit at eight, for a total of thirty-seven so far this month. These numbers are derived from the FDA’s All Approvals page here. Compared […]
OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing. We missed the approval actions by one. OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of […]
Today, the FDA issued a draft guidance titled Using the Inactive Ingredient Database (here). The guidance describes how to use the inactive ingredient database (IID) and its limitations. FDA has been using the IID since 1987 and has committed to updates throughout the year that provide more current and useful information. Excipients are constantly being […]
New MaPP (Manual of Policy and Procedures) 6004.3 (here) fully outlines the internal process that FDA will go through for reviewing and recommending safety label changes (SLCs) for NDAs, BLAs, and ANDAs. It also discusses the process for FDA-mandated and -ordered label changes “when implementing section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act […]
In a Federal Register Notice (here) published today, the FDA announced a Compliance Policy which will exercise enforcement discretion relative to 503A compounders using the bulk drug, Oxitriptan, for compounding oral forms of the drug. Remember, “FDA issued a final rule (84 FR 4696) (“February 19, 2019, final rule”), which established the list of bulk […]
