FDA opens up generic competition

March 12, 2015

FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.

FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.

“FDA adopted this process as a means to develop and disseminate product-specific BE [bioequivalent] recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations,” according to the notice.

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The bioequivalence recommendations apply to the Abbreviated New Drug Applicaton (ANDA) process and affect popular drugs such as avanafil (Stendra, Endo), lorcaserin HCl (Belviq, Eisai) and ticagrelor (Brilinta, AstraZeneca). FDA’s new draft guidance for industry on product-specific BE recommendations includes drug products containing the following active ingredients: avanafil, azilsartan kamedoxomil; chlorthalidone, buprenorphine HCl; naloxone HCl; chlorpheniramine maleate; ibuprofen; cyclosporine; deferiprone; desoximetasone; diclofenac; diphenhydramine HCl; naproxen sodium, loperamide HCl, minocycline HCl, oxybutynin chloride, potassium chloride and pyrimethamine.

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Interested parties must submit either electronic or written comments on the draft by May 8, 2015.

The guidance stems back to FDA’s Federal Register notice of June 11, 2010, (75 FR 33311), when FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products."

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