FDA, Regulatory

FDA releases flurry of new, revised drug-specific guidance documents

In an effort to provide support for abbreviated new drug applications, the FDA on Thursday issued a flurry of product-specific recommendations, providing guidance for companies looking to develop generic versions of a number of popular medicines, including Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

In total, new guidance was published for 32 drugs. On top of these new drafts, FDA released 19 revised guidance documents, including one for companies looking to develop generics of Eli Lilly’s erectile dysfunction drug Cialis, and other glaucoma treatments and antibiotics.

In addition, FDA on Thursday released Federal Register notices and draft guidance documents on two other products that are unique.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But FDA said Thursday that it will consider any comments on the draft guidance before responding to Boehringer’s citizen petition.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FDA again said it will consider any comments on the new draft guidance documents before responding to GSK’s citizen petition.


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.



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