On November 29, 2011, FDA reportedly approved an application for a generic of BAYER’s trademarked YAZ by WATSON PHARMACEUTICALS. Related news reports , and PR releases indicate that WATSON is embroiled in a patent dispute with BAYER over the product. The new generic to enter into the DRSP (DROSPIRENONE) family is to be called VESTURA.
FDA has scheduled hearings during December 2011 of expert panels to discuss the already confirmed and significantly higher risk of blood clots DRSP (DROSPIRENONE) containing birth control pills present to users. Civil jury trials over the pills are set for January 2012. As a result, these pills will remain in the news and public spotlight as some FDA action is anticipated regardless of this recent FDA approval.
The generic market is a potential money maker for pharmaceutical companies as trademarked pills approach the “patent cliff” where a pill loses initial patent protection and open competition can begin on pricing and manufacture.
Notably, there are already a number of DRSP (DROSPIRENONE) generics approved by FDA.
The YASMIN generics, or related pills, include the following:
What impact, if any, FDA’s December 2011 hearings will have on DRSP (DROSPIRENONE) labeling, warning or packaging remains open to some debate. We will provide updates as they become available or are publicly reported.
Sadly, the Vermont Journalism Trust, through VTDIGGER.ORG is reporting that 21 year old, April Bapp, died on 11.12.11 from use of DRSP (DROSPIRENONE) generic – OCELLA. The original story, and obituary, were originally published in the BARTON CHRONICLE, and re-published in VTDIGGER.ORG’s, “YOUNG WOMAN’S DEATH LEADS TO QUESTIONS ABOUT POPULAR CONTRACEPTIVE KNOWN AS YAZ“. The original reporter, Tena Starr, explained how Bapp suffered from difficulty breathing and was transported by her parents to a hospital prior to passing away. An autopsy revealed that she died from a blood clot in her heart with secondary cause of death being identified as oral contraceptive. Notably, she was taking the YASMIN generic OCELLA which was at one point actually manufactured along with other DRSP (DROSPIRENONE) containing contraceptives in Germany by BAYER pursuant to a licensing agreement. OCELLA was recalled, as noted in FDA ENFORCEMENT REPORTS on 11.25.09, along with YAZ boxes for failure to meet current good manufacturing practices.
Only yesterday (as noted above), a new YAZ generic – VESTURA – was approved for manufacture by WATSON PHARMACEUTICALS. Safety and effectiveness of DRSP (DROSPIRENONE) pills, and their increased risk of blood clots, will be the subject of FDA hearings on 12.8.11. Will FDA experts recommend stronger warnings, yet another – which will be the 3rd label change to warnings – or can the status quo continue despite FDA funded studies confirming significantly increased risk of blood clots? On the heels of another generic approval, and the reports of April Bapp’s death, all interested parties will be under public scrutiny as a Generation of Girls & Women have already been subjected to a decade of risk with “evolving warnings” that have resulted in over 10,000 lawsuits. We will update this site as more information relating to these pills, their future, and FDA’s action plan becomes available.
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