One-dose “morning after” pill?
This article was originally published in The Tan Sheet
HRA Pharma currently is conducting its own studies on one-dose levonorgestrel 1.5 mg drug for emergency contraception to be submitted to FDA in early 2004, the Paris-based firm says. HRA Pharma says it is not sure whether the NDA will be submitted for Rx or OTC status, but noted it likely would be difficult to switch OTC from Rx in light of FDA's recent "not approvable" letter to Barr Labs (1"The Tan Sheet" May 10, 2003, p. 5). Barr's current EC regimen includes two pills of levonorgestrel .75 mg taken 12 hours apart...
You may also be interested in...
Barr Labs will continue to work with FDA toward approval of emergency contraceptive Plan B (levonorgestrel .75 mg) for OTC use, the company said in a May 6 statement
Cosmetics Europe Talks Microplastic: ECHA Frustrations, ‘Value Judgments’ And International Trade Uncertainty
The European Chemicals Agency's microplastic restriction proposal received committee backing in 2020 without changes sought by the cosmetics industry, which faces €15bn in projected costs and scarce alternatives at present. It may come down to EU Member States to decide whether the ECHA restriction proposal is proportionate in balancing environmental goals and socio-economic impacts.
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.