Regulatory Focus™ > News Articles > Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents

Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents

Posted 19 October 2017 | By Zachary Brennan 

Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents

The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

On top of the new drafts, FDA released 19 revised guidance documents, including one for companies looking to develop generics of Eli Lilly’s erectile dysfunction drug Cialis (tadalafil) and other glaucoma treatments and antibiotics, among others.

Both the new draft and revised guidance documents are part of FDA’s efforts to provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).

In addition, FDA on Thursday released Federal Register notices and draft guidance documents on two other products that are unique.

In its product-specific guidance for tiotropium bromide inhalation powder, the agency notes it initially approved Boehringer Ingelheim’s new drug application for the product, known as the Spiriva Handihaler, in 2004, though in 2012 Boehringer submitted a citizen petition requesting that FDA adopt and apply certain requirements for generic versions of the bronchodilator.

But FDA said Thursday that it will consider any comments on the draft guidance before responding to Boehringer’s citizen petition.

Similarly, FDA in 2009 approved GlaxoSmithKline’s treatments known as Serevent Diskus, Flovent HFA and Flovent Diskus 100, and the company submitted a citizen petition requesting that FDA withhold approval of any ANDA or 505(b)(2) application for generic oral inhalation products containing salmeterol xinafoate and/or fluticasone propionate unless certain conditions were satisfied, including some related to demonstrating bioequivalence.

FDA again said it will consider any comments on the new draft guidance documents before responding to GSK’s citizen petition.

Product-Specific Guidances for Generic Drug Development

Draft Guidance on Tiotropium Bromide

Draft Guidance on Salmeterol Xinafoate

Draft Guidance on Fluticasone Propionate (powder)

Draft Guidance on Fluticasone Propionate (aerosol)

Editor's note: This story has been updated on 10/20/17 to note that one of the new product-specific guidance documents is for Amedra Pharmaceuticals' Adrenaclick (epinephrine), not Mylan's EpiPen (epinephrine). FDA posted the EpiPen product-specific guidance in 2016 here. "FDA does not consider EpiPen and Adrenaclick to be therapeutically equivalent; generic drug applicants must develop their product to match one specific RLD [reference listed drug] epinephrine auto injector," a spokesman told Focus.


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