With the Decongestant SNAFU, the FDA Tries Something New
It’s easy to understand how a medicine like phenylephrine got onto pharmacy shelves in the first place. The common decongestant, used most often as an ingredient in multidrug cold medications like DayQuil and Sudafed PE, was initially designated as “safe and effective” by the Food and Drug Administration (FDA) in 1976, when the agency was newly—and less stringently than today—greenlighting drugs that had been on the market for years before the agency had established any efficacy standards. After a full review of 14 studies (12 unpublished and two published) from pharmaceutical companies—...
Source: TIME: Health - September 14, 2023 Category: Consumer Health News Authors: Haley Weiss Tags: Uncategorized healthscienceclimate Source Type: news
Punjab-based drugmaker asked to stop manufacturing after samples found to be of non-standard quality: Govt
Punjab-based drugmaker QP Pharmachem Ltd has been directed to halt all manufacturing activity after the World Health Organisation (WHO) issued an alert warning that samples of Guaifenesin syrup it produced were of substandard quality. The Central Drugs Standard Control Organisation, in conjunction with Punjab's state drugs authority, had investigated the manufacturer after reports of the contamination in the Marshall Islands and Federated States of Micronesia. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 11, 2023 Category: Pharmaceuticals Source Type: news
Another Indian pharma manufacturer in news after WHO's substandard medicine alert
The alert was issued for a batch of substandard (contaminated) Guaifenesin Syrup TG Syrup. The substandard product was identified in the Marshall Islands and Micronesia and reported to WHO on 6 April 2023, a WHO statement said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 25, 2023 Category: Pharmaceuticals Source Type: news
Robitussin Ac (Guaifenesin and Codeine) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 17, 2022 Category: Drugs & Pharmacology Source Type: news
Hycotuss (Hydrocodone Bitartrate and Guaifenesin) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 5, 2022 Category: Drugs & Pharmacology Source Type: news
Deconex DMX Tablet (Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 8, 2022 Category: Drugs & Pharmacology Source Type: news
Deconex DM Capsule (Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 27, 2022 Category: Drugs & Pharmacology Source Type: news
Mucinex DM (guaifenesin and dextromethorphan hydrobromide)
Title: Mucinex DM (guaifenesin and dextromethorphan hydrobromide)Category: MedicationsCreated: 11/8/2021 12:00:00 AMLast Editorial Review: 11/8/2021 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - November 8, 2021 Category: Drugs & Pharmacology Source Type: news
Xtrelus (Hydrocodone Bitartrate and Guaifenesin Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 8, 2021 Category: Drugs & Pharmacology Source Type: news
Mucinex (Dextromethorphan Guaifenesin Bi-Layer Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 4, 2021 Category: Drugs & Pharmacology Source Type: news
Organidin NR (Guaifenesin) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 11, 2021 Category: Drugs & Pharmacology Source Type: news
Entex-T (Guaifenesin and Pseudoephedrine Hydrochloride Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 19, 2021 Category: Drugs & Pharmacology Source Type: news
Aurobindo Pharma gets USFDA nod for its expectorant tablets
The company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture its generic Guaifenesin extended-release tablets in the strengths of 600 mg and 1,200 mg. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 23, 2019 Category: Pharmaceuticals Source Type: news
Deconex IR Tablets (Guaifenesin and Phenylephrine Hcl) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 24, 2019 Category: Drugs & Pharmacology Source Type: news
Entex LQ (Guaifenesin and Pseudoephedrine Hydrochloride Liquid) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 18, 2019 Category: Drugs & Pharmacology Source Type: news
