Low-dose Yasmin review
Executive Summary
FDA extends review deadline for low-dose version of Berlex' Yasmin oral contraceptive by three months to Nov. 16. The formulation contains .02 mg ethinyl estradiol compared to .03 mg in regular Yasmin. At the time of the NDA filing in October 2003, Schering projected a 2004 launch for the low-dose product. The company said it is now "confident" of a 2005 launch...
You may also be interested in...
Berlex’ Yaz “approvable”
Berlex' oral contraceptive Yaz (ethinyl estradiol 20 mcg/drospirenone 3 mg) is "approvable" at FDA, company says Nov. 18. Schering AG subsidiary says FDA seeks additional data to support the pill's "unique dosing regimen" of 24 days of active pills, in contrast to the standard 21-day regimen. Berlex plans to submit data "to support the clinical benefit of the additional three days of active pills in each cycle" by the end of 2004. Yaz is the low-dose version of Yasmin; FDA had extended is review timeline for the product (1"The Pink Sheet" July 26, 2004, In Brief)...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.