federal_register: 2011-19566

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-19566 Proposal To Refuse To Approve a Supplemental New Drug Application for Bromday (Bromfenac Ophthalmic Solution), 0.09%; Opportunity for a Hearing Notice The Food and Drug Administration (FDA), the Director of the Center for Drug Evaluation and Research (the Center Director), is proposing to refuse to approve a supplemental new drug application submitted by ISTA Pharmaceuticals, Inc. (ISTA), for a new 2.4 milliliter (mL) fill size for Bromday (bromfenac ophthalmic solution), 0.09%. This notice summarizes the grounds for the proposal of the Center for Drug Evaluation and Research (CDER) and offers ISTA an opportunity to request a hearing on the matter. 2011-08-03 2011 8 https://www.federalregister.gov/documents/2011/08/03/2011-19566/proposal-to-refuse-to-approve-a-supplemental-new-drug-application-for-bromday-bromfenac-ophthalmic https://www.govinfo.gov/content/pkg/FR-2011-08-03/pdf/2011-19566.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA), the Director of the Center for Drug Evaluation and Research (the Center Director), is proposing to refuse to approve a supplemental new drug application submitted by ISTA Pharmaceuticals, Inc. (ISTA), for a new...  

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