Enforcement Report - Week of January 10, 2024
Enforcement Report - Week of June 7, 2023
Cough syrups should not be used routinely in every upper respiratory tract infection. Only in a select few cases where the cough is dry, we may use cetirizine. Dextromethorphan-containing syrups should be given sparingly in such situations. Phenylephrine-containing syrups should not be used as they may cause hypertension. For a dry cough, home remedies like warm saline gargling thrice a day and steam inhalation are the best says Dr Abhishek Madhura
NEW YORK, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced that it has enrolled the first patient in the ADVANCE-2 trial of AXS-05, an investigational treatment for Alzheimer’s disease (AD) agitation.
Enforcement Report - Week of May 4, 2022
Enforcement Report - Week of February 9, 2022
GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children`s Robitussin®
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
ALISO VIEJO, Calif., Nov. 12, 2019 /PRNewswire/ -- Avanir Pharmaceuticals, Inc., a pharmaceutical company committed to delivering innovative central nervous system (CNS) solutions to improve the lives of patients and their care communities, announced today that it will continue the clinical development program of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with Alzheimer's dementia. The decision is based on insights derived from detailed analysis of data from the first and second phase 3 AVP-786 clinical trials. Preliminary results of the first and second phase 3 clinical trials (15-AVP-786-301 and 15-AVP-786-302) were released March 25 and September 27, 2019, respectively.