Sandoz' Parlodel
Executive Summary
FDA's Fertility and Maternal Health Drugs Advisory Committee will meet June 1-2 to discuss the use of Parlodel for lactation prevention. At issue is whether any potent drug should be used to suppress postpartum lactation. Sandoz submitted comments Feb. 15 to FDA in response to a citizen petition filed Nov. 29 by Health Research Group and the National Women's Health Network, which called for the deletion of lactation supression labeling from four products, including Parlodel, on the grounds that the natural resolution of lactation does not warrant the risks of reported side effects ("The Pink Sheet" Dec. 5, T&G-12).
You may also be interested in...
Amgen/AstraZeneca’s Tezepelumab Cuts Asthma Exacerbations By 56%
Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics.
Sarepta’s Next-Generation Drugs Draw Attention Amid ‘Incremental’ Approval
The RNA drug’s accelerated approval brings Sarepta’s exon-skipping market share to nearly 30%.
COVID-19 Will Forever Change Workplace, But Not Necessarily For The Better, Merck’s Frazier Says
Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: