Enforcement Report - Week of January 10, 2024
Enforcement Report - Week of October 25, 2023
Teva's Generic Oxymetazoline HCL Receives Approval in the U.S.
Enforcement Report - Week of March 02, 2022
Taro Pharma`s Generic Oxymetazoline HCL Receives Approval In US
Taro Pharms Generic Oxymetazoline Hydrochloride Receives Tentative Approval In US
The powder-in-bottle (PIB) or granules/powder for suspension approach is used to accelerate formulation development and introduce new chemical entities into Phase I clinical trials. The approach consists of granulating or compounding the active pharmaceutical ingredient (API) into a solution or a suspension in the clinic before dispensing by oral administration.
BRIDGEWATER, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (Osmotica), today announced that JAMA Ophthalmology has published pooled analysis of data from two Phase 3 clinical trials of Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for treatment of acquired blepharoptosis (ptosis) in adults. Upneeq, a novel pharmacologic agent, is the first and only ophthalmic formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of ptosis. Upneeq is a preservative-free eye drop administered once daily to the ptotic eye(s).
RVL Pharm’s Upneeq (Oxymetazoline Hydrochloride) Receives Approval In US
RVL Pharm’s Generics Glycopyrrolate Receives Approval In US