FDA clarifies results of recent advisory committee meeting on oral phenylephrine

… da-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine … [9/14/2023] FDA held a Non-prescription Drug … Sept. 11-12, 2023, to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter … committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data …

Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance

… gent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-phenylephrine-hydrochloride-injection … Sagent … announced the voluntary nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). This … Inc. Sagent has initiated this voluntary recall of Phenylephrine Hydrochloride Injection, USP to the user level …

Phenylephrine/Ketorolac Written Request

… of the Federal Food, Drug, and Cosmetic Act for OMS302 (phenylephrine-ketorolac injection) 1%/0. (b) (4)%. We also … Plan (PSP). To obtain needed pediatric information on phenylephrine and ketorolac , the Food and Drug … you submit information from the study described below. μM phenylephrine/ (b) (4) μM ketorolac), and a …

Phenylephrine N203510 Clinical PREA

… 21, 2013 Martin P. Nevitt, M.D., M.P.H. February 20, 2013 Phenylephrine Hydrochloride Ophthalmic Solution, 2.5 % and … Clinical Review Martin P. Nevitt, M.D. M.P.H. NDA 203510 (phenylephrine ophthalmic solution) 0.25% and 10% Table of … Clinical Review Martin P. Nevitt, M.D. M.P.H. NDA 203510 (phenylephrine ophthalmic solution) 0.25% and 10% 7.2 Adequacy …

Phenylephrine N203510 Statistical PREA

… NDA/BLA #: NDA 203510 Supplement #: 0000 Drug Name: Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% and 10% … 2.1.1 Phenylephrine … 2: Effects on pupil dilation of four concentrations of phenylephrine based on Chawdhary (1984) … 6 Table 3: Change in pupil size after tropicamide and phenylephrine based Yospaiboon (2004) …

Phenylephrine N203510 Clinpharm PREA

… Date(s): September 21, 2012 PUDFA: March 21, 2013 Drug Phenylephrine hydrochloride Product/Formulation; Strength(s) Phenylephrine hydrochloride ophthalmic solution 2.5% and 10% … Submission Type 505(b)(2) ; Priority BACKGROUND Phenylephrine is an alpha-adrenergic receptor sympathetic …

214_205388S6 phenylephrine and ketorolac clinical bpca

… Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 2 … Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 3 … Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 5 …

215_205388S6 phenylephrine and ketorolac statistical bpca

… #: Supplement #: NDA 205388 006 Drug Name: Omidria™ (Phenylephrine HCL/Ketoroloc Tromethamine) Indication(s): … NDA supplement was a pediatric use supplement. Omidria® (phenylephrine and ketorolac 1% / 0.3% (also refer to as … Study 007 was a randomized, parallel-group, double-masked, phenylephrine(PE)-controlled study of OMS302 in young …

213_205388S6 phenylephrine and ketorolac CDTL clinical bpca

… Boyd, MD, Wiley Chambers, M.D. NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% … Boyd, MD, Wiley Chambers, M.D. NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% … OMS302) is a fixed-dose combination product containing phenylephrine hydrochloride (PE), an α1-adrenergic receptor …

N203826-000 phenylephrine NC ltr (6-8-17)

… of the Federal Food, Drug, and Cosmetic Act (the Act) for phenylephrine hydrochloride injection, USP, 10 mg/mL, which … Reference ID: 4109102 ( … /media/154280 … N203826-000 phenylephrine NC ltr (6-8-17) …

N203826-000 phenylephrine PREA Response (7-21-17)

… … /media/154281 … N203826-000 phenylephrine PREA Response (7-21-17) …

Use Caution When Giving Cough and Cold Products to Kids

… contain the decongestants ephedrine, pseudoephedrine, or phenylephrine, and the antihistamines diphenhydramine, …

Unapproved Prescription Cough, Cold, and Allergy Products

… A TAN 12X SUSPENSION PYRILAMINE TANNATE 30 MG 65162 0530 PHENYLEPHRINE TANNATE 5 MG ACCUHIST DM GUAIFENESIN 50 MG … MALEATE 8 MG 066440 2376 METHSCOPOLAMINE NITRATE 2.5 MG PHENYLEPHRINE HYDROCHLORIDE 20 MG AH CHEW SUSPENSION CHLORPHENIRAMINE TANNATE 35 MG 59196 0015 PHENYLEPHRINE TANNATE 25 MG AH CHEW ULTRA CHEWABLE TABLET …

Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

… 05446-1179-03 PHENOL, STERILE (PF) 6% 05446-1476-05 PHENYLEPHRINE / TROPICAMIDE / KETOROLAC / CIPROFLOXACIN (PF) 10% / 1% / 0.125% / 0.3% 05446-1270-01 PHENYLEPHRINE HCL 0.1 MG/ML 05446-1544-10 PHENYLEPHRINE HCL 0.1 MG/ML 05446-1545-05 PHENYLEPHRINE HCL …

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility

… Chloride 500mL IV Bag, Compounded 07242019@9 10/22/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL … fill in a 3mL Syringe, Compounded 08212019@11 10/20/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL fill in a 5mL SDV, Compounded 07172019@16 9/15/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL …

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility

… Chloride 500mL IV Bag, Compounded 07242019@9 10/22/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL … fill in a 3mL Syringe, Compounded 08212019@11 10/20/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL fill in a 5mL SDV, Compounded 07172019@16 9/15/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL …

Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling

… 10-vials per carton, contained 10-vials mis-labeled as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL.  … paralysis as part of general anesthesia is administered phenylephrine instead would not receive any skeletal muscle … is a reasonable probability that a patient who requires phenylephrine to increase their blood pressure, such as …

July - September 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

… (generic product for the trade name Bloxiverz) Certain phenylephrine hydrochloride product (generic product for the … errors associated with look-alike neostigmine and phenylephrine container labels The container label and carton … revised in November 2022 to differentiate the product from phenylephrine hydrochloride. Ocrevus (ocrelizumab) Pyoderma …

UPDATED INFORMATION: April 12, 2023: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement - 04/12/2023

… discuss the adequacy of efficacy data available for oral phenylephrine as a nasal decongestant and whether oral nasal decongestants phenylephrine hydrochloride and phenylephrine bitartrate should be reclassified as not …

Postmarket Drug and Biologic Safety Evaluations Completed from July 2016 – September 2016

… identified. No regulatory actions required at this time. Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and … to determine if regulatory action is required. Vazculep (phenylephrine hydrochloride) injection for intravenous use   … safety issue of product selection error between Vazculep (phenylephrine hydrochloride) and Bloxiverz (neostigmine …

Rulemaking History for OTC Nasal Decongestant Drug Products

… and Labeling Nonmonograph Ingredients Combination Products Phenylephrine Bitartrate Pseudoephedrine Drug Interaction … 3/19/2007 72FR12730 Nasal Decongestant Drug Products: Phenylephrine Bitartrate Proposed Rule Date FR Citation …

Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

RiteAid Corporation - 643207 - 10/19/2022

… listing file includes an extra active ingredient, phenylephrine hcl, that the label does not. As such, your … include dextromethorphan hydrobromide, guaifenesin, and phenylephrine hcl, while the labeling only includes …

Procter & Gamble Manufactura S. de R.L. de C.V. - 650837 - 03/14/2023

… dextromethorphan hbr, doxylamine succinate, and phenylephrine, while the active ingredients included in the … file in (SPL) are acetaminophen, dextromethorphan hbr, phenylephrine, and guaifenesin. The active ingredient …

2018 First Generic Drug Approvals

… during surgery or mechanical ventilation 20 210334 Phenylephrine Hydrochloride Injection USP, 10 mg/mL SingleDose Via  Cipla Limited Phenylephrine Hydrochloride 4/27/2018 For increasing blood … in such settings as septic shock or anesthesia 19  210333 Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 …