ERRIN

FDA-2026-P-3630

Rising Pharma Holdings, Inc. submitted this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner issue a declaration permitting submission of an Abbreviated New Drug Application for Tamsulosin Hydrochloride Capsules, U

FDA-2025-P-6021

Orrick, Herrington & Sutcliffe LLP, representing a company developing adult-derived stem cell products for regenerative therapy, petitioned the FDA to amend 21 C.F.R. § 1271.10(a) to allow stem cell products to be regulated solely as section 361 HCT/Ps (human cells, tissues, or cellular and tissue-b

FDA-2022-P-0160

Ferring Pharmaceuticals, Inc. submitted a citizen petition on February 9, 2022, requesting that the FDA require in vivo bioequivalence studies for any abbreviated new drug application (ANDA) under section 505(j) or new drug application (NDA) under section 505(b)(2) that references Firmagon (degareli

FDA-2016-P-4093

Ferring Pharmaceuticals Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act on November 22, 2016, challenging FDA's handling of desmopressin applications for nocturia treatment. Ferring requests that FDA refrain from approving Serenity Pharmaceuticals' new

FDA-2014-P-1593

Buchanan Ingersoll and Rooney PC, on behalf of Ferring Pharmaceutical, filed a citizen petition requesting that the FDA take certain regulatory actions concerning pharmaceutical products. The specific details regarding the drug involved and the exact regulatory mechanism or requested action are not

FDA-2013-P-0119

Ferring Pharmaceuticals, Inc., through counsel, filed this citizen petition under Federal Food, Drug and Cosmetic Act section 505 and related regulations, requesting that the FDA amend the exclusivity period for Prepopik (citric acid; magnesium oxide; sodium picosulfate) oral solution, approved unde