Happy May Day!
As much of the world celebrates the worker, here we toil to bring you this week’s latest. We are well into the second quarter of the year – hard to believe – and are having those kinds of days that require we dress in layers. The kind of day where you can go out and see people still wearing heavy coats and stocking caps walking next to the person wearing shorts, t-shirt and flip-flops. There is weather for everyone.
And here are a few things for you.
- FDA Announces Proposed Rule on OTC Antiseptics – The agency announced this week that it was issuing a proposed rule that would amend the 1994 tentative final monograph for OTC antiseptic products. The agency is focused on the use of such antiseptics by health care professionals, particularly in a hospital setting, where there is frequent exposure due to heavy use. While the 1994 monograph proposed certain active ingredients as “generally recognized as safe” (GRAS), the agency is now looking for additional safety data to support the use of such ingredients as well as some additional safety data that will include in vitro data that characterizes the antimicrobial properties of the ingredients along with in vivo clinical simulation studies. The proposed rule is open for public comment for 180 days (due October 28, 2015) and the docket can be found here.
- Guidance Documents for Biosimilars Issued – The agency posted three final guidance documents related to biosimilars this week: (1) Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; (2) Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and (3) Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act. That is relatively fast action given that the drafts of these guidances were put out only in February of 2012.
- Generic Abilify Approved, OPDP Letter on Brand Ablify – FDA announced that it was approving a generic version of Abilify (aripiprazole), an atypical antipsychotic drug approved for use in treating bipolar disorder and schizophrenia in multiple strength and dosage forms. Coincidentally, the agency’s Office of Prescription Drug Promotion (OPDP) also posted its fourth regulatory action letter of the year – an untitled letter – addressed to the brand name manufacturer of Abilify.
That’s it for me this week. Have a good weekend and for those of you who are celebrating the holiday today, enjoy.
CORRECTION -5.2.15 – A reader wrote in to point out that the FDA draft guidance on biosimilars was issued in February 2012, not February of this year and that was indeed correct. Apologies for the error. The text has been corrected above.