FDA Proposes Guidance for Generic Drug Development

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The FDA is seeking comments on 28 new and 15 revised recommendations providing product-specific guidance on the design of bioequivalence studies to support Abbreviated New Drug Applications (ANDAs).

The FDA is seeking comments on 28 new and 15 revised recommendations providing product-specific guidance on the design of bioequivalence studies to support Abbreviated New Drug Applications (ANDAs).

The new recommendations apply to drugs containing tofacitinib citrate; vandetanib; acyclovir; budesonide; buprenorphine hydrochloride and naloxone hydrochloride; cobicistat, elvitegravir, emtribcitabine, and tenofocir disoproxil dumarate; and raltegravir potassium, among others.

Many of the medications on the FDA’s list were approved within the last 5 years, although several were approved before 2009.

The newly revised bioequivalence recommendations involve drugs containing several adapalene formulations, doxorubicin hydrochloride injection, methylprednisolone acetate, and hydrocodone bitartrate and ibuprofen, among others.

The latest set of bioequivalence guidelines were developed using the FDA’s Bioequivalence Recommendations for Specific products, which explains the process used to make these types of recommendations available to the public.

Although interested parties can comment on the recommendations at any time, the FDA advises submitting electronic or written comments by March 2, 2015, before it begins work on the final versions.

Electronic comments can be submitted through http://www.regulations.gov, and written comments can be sent to:

The Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, Maryland 20852

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