> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Perrigo Approval for First Generic ProAir HFA
- URL: https://www.fdaweb.com/perrigo-approval-for-first-generic-proair-hfa/
- Published: 2020-02-25T12:00:00.000Z
- Updated: 2026-09-14T16:04:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146171

FDA has approved a Perrigo Pharmaceutical ANDA for the first generic of Teva’s ProAir HFA (albuterol sulfate) inhalation aerosol for treating or preventing bronchospasm in patients four years of age and older with reversible obstructive airway disease. It is also indicated for preventing exercise-induced bronchospasm in patients four years of age and older.

The approval is part of FDA’s actions to increase approval of complex generics. In 2016, the agency issued a revised [draft product-specific guidance](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZOSQDLHSkv6X7MjPjqY-2FZq4ia-2FF-2BD4kU9BxxpGHeRTxHjLMrotpFJAUBVg6f5maU7QSwS3xFxvJPGPmhWuGzzwrwfIvLTsvmeH8SEx6Yz2t-2F-2Bo2O4ZKweBBUNhPtThzxEXIytBLJPMP8-2BNICgkCZT-2FF7vvwK5aWoau3jtx5NRLz-2B8STxOAtCmYYW6rxLC0wnoQ-3D-3DDiev%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWVj17wwJHrlLPp10lfIXiQDrw82TFF8QPM4kKVnvlG-2BPomZGCE92P2HPBm-2BHUZMx-2FBFhLz-2Fpp1j-2FRgtJrnoOHDv1pSWD6K3A3uCnaQjcOtaCI6maLo2jYTjqSJg5-2BAsaqk9SIba5D7uFsTz3qtaOliMpIM1iBvm05SuDtCPV-2BwO6cYxKVnculHeEBW6bn-2BkZCZEuxcPiT9vq1u4RyAtt38K6fr2sv5i6xJ9KFfBKJ-2BPq23AhFaRIkDGy-2FtU03qrEqnNGmRzsuX5KKMSw1yq4NCOEJefYLoJZiN4sY-2FliPAcJY-3D&ref=fdaweb.com) for proposed generic albuterol sulfate metered dose inhalers, including drug products referencing ProAir HFA. Among other things, the draft guidance provides bioequivalence recommendations.

An [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-proair-hfa?ref=fdaweb.com) notes that this year it will continue to advance additional policies to promote generic competition for [complex generic drug products](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZLJsxjG040N2rwPdqKli79AfTsXoL3-2FSVAi819nO3gmtVPQt5oXYYhF245fMm2m-2BStHNr7aCa0ML9a9DP106M-2BLAze9brmrjsipCka-2BFiH-2Bs2aq4vuy38dv1nUAOZi5am0M8iVyI-2BDdgsCovPfcCg3A-3DmgFm%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWVj17wwJHrlLPp10lfIXiQDrw82TFF8QPM4kKVnvlG-2BPomZGCE92P2HPBm-2BHUZMx-2FBFhLz-2Fpp1j-2FRgtJrnoOHDv1pSWD6K3A3uCnaQjcOtaCI6maLo2jYTjqSJg5-2BAsaqk9SIba5D7uFsTz3qtaOliMr-2F-2FqS-2BLMDvSVtW0zn-2BPzhpHacMQgv-2FKfPobKb5d-2B1AmoLcU5k84c7zY2q7iE0RAAPWr-2BvRAmAkMK-2FbCGhltqK9kHvtZ-2FStEAPrEuAP2c5YUEURlIBX1VitZmVJUsW3Kw6japjogqUUhqDnzdGxHRWw-3D&ref=fdaweb.com). “Among other steps, the agency intends to publish additional guidance documents to aid in the development of specific complex generic drug products,” it says. “The FDA also plans to publish a series of guidances to address regulatory and scientific challenges that make it generally more difficult to develop complex generic drug products because of their complex formulation or mode of delivery.”

FDA says it also intends to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, it is going to help advance “new analytical tools and in vitro tests that may provide additional accurate, sensitive and reproducible ways to support development of complex generic drugs,” the release says. “Better tools can reduce complex generic drug development time and cost and can inform regulatory decisions.”