A few days ago, the FDA published a guidance document titled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions (see here) that describes three checklist attachments for various types of ANDAs and related submissions. The checklists are identified as being voluntary, but the OGD suggests that not only can they aid applicants in ensuring […]
Prescription Medication Information (PMI) will, if FDA has its way, replacing medication guides and other information provided to patients. The goal of the new PMI is to “highlight essential information that the patient needs to know about the prescription drug product and basic directions on how to use the product. The pre-publication of the proposed […]
A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]
Today, the FDA released another batch of Product‑Specific Guidances (PSGs), outlining its current thinking on the bioequivalence (BE) testing requirements for generic products – twenty‑five new BE guidances and twenty‑one revised guidances. The listing can be found here. The FDA has various goals regarding publication of these PSGs that are tied to getting information to […]
With the generic product approvals currently listed through May 15th on the All Approvals website (here), OGD has issued 30 full approval actions and 10 tentative approval actions for the month of May so far. Hopefully this will bode well for total approvals for the full month. We do have a major holiday coming up […]
Yahoo News reported this morning (here) that the Supreme Court refused to wade into the waters of the skinny label case regarding the Teva V GSK case. We have written extensively about the skinny label issue (here, here, here, here, , here, here, here here, and here. That’s a lot of discussion, but this is […]
In the prepublication of the Federal Register (here) which will publish on May 15, 2023, the FDA announced that Makena (Hydroxyprogesterone Caproate injection) will be removed from the Orange Book (OB) along with eight (8) generic applications that referenced Makena as the RLD in its application. Makena was originally approved in 2011 under the accelerate […]
While we know there are probably thousands of unapproved drug products being marketed in the US, many of which claim to be dietary supplements which have undeclared drugs in their composition, the danger of these products cannot be understated. Just search the web for erectile disfunction products, weigh loss products, products claiming to prevent, cure […]
Based on the longstanding knowledge that diethylene glycol (DEG) and ethylene glycol (EG) are dangerous at levels that may exceed USP‑NF limits and because of the recent misadventures and deaths resulting from these incidents, the FDA has revised a 2007 guidance to provide further recommendations regarding the identification and quantification of these contaminants in drug […]
Coming off the March total of 117 (ninety‑six full approvals and twenty‑one tentative approvals), April’s numbers are good but fall short of any big records. April saw the OGD unofficially issue sixty‑four full‑approval actions and eleven tentative‑approval actions for a total of seventy‑five approval actions. If these figures hold firm when the official numbers are […]
