Yaz, Yasmin and Ocella Background & FDA Documents

Yasmin was originally developed by Berlex Laboratories, a U.S. affiliate of Schering AG, Germany. It was approved for use on May 11, 2001. Yasmin has 21 active pills and seven placebo pills.  Ocella is the generic equivalent.

In 2006, the drug company, Bayer, acquired Berlex and its parent company and marketed a more recent version of Yasmin, called YAZ that has 24 active pills and four placebo pills. The YAZ (24-day) formulation is FDA approved as a method of birth control, as well as a treatment for premenstrual dysphoric disorder (PMDD) and acne.

Yasmin/YAZ/Ocella is the first type of birth control to contain a different kind of hormone, called drsp or drospirenone (pronounced dros-peer-eh-known). Yasmin contains 3 mg drospirenone and 30 mcg ethinylestradiol per tablet. YAZ contains 3 mg drospirenone and 20 mcg ethinylestradiol per tablet.

The following FDA documents relating to Yasmin and YAZ are available by clicking on the following links below:

Yasmin Drug Details

YAZ Drug Details

Yasmin 2003 Warning Letter Part 1 of 2

Yasmin 2003 Warning Letter Part 2 of 2

YAZ 2008 Warning Letter

YAZ Jan. 2007 Safety Labeling Change

YAZ 2007 Prescribing Info

YAZ 2007 Summary Patient Package Insert

Yasmin FDA Consumer Information Sheet

FDA Birth Control Q & A

2004 Berlex Approval Letter for Yaz

Yaz Approval History

FDA Yaz Approval Letter

FDA Yaz Approvable Letter

FDA Yaz Medical Review Part 1

FDA Yaz Medical Review Part 2

FDA Yaz Medical Review Part 3

FDA Yaz Medical Review Part 4

FDA Yaz Medical Review Part 5

FDA Yaz Chemistry Review

FDA Yaz Pharmacology Review

FDA Yaz Statistical Review

FDA Yaz Clinical Pharmacology Biopharmaceutics Review

FDA Yaz Proprietary Name Review

FDA Yaz Administrative Documents and Correspondence Part 1

FDA Yaz Administrative Documents and Correspondence Part 2

FDA Yaz Administrative Documents and Correspondence Part 3

FDA Yaz Administrative Documents and Correspondence Part 4

FDA Yaz Administrative Documents and Correspondence Part 5

FDA Yaz Administrative Documents and Correspondence Part 6

FDA Yaz Administrative Documents and Correspondence Part 7

FDA Yaz Administrative Documents and Correspondence Part 8

FDA Yaz Administrative Documents and Correspondence Part 9

FDA Yaz Administrative Documents and Correspondence Part 10

If you or someone you love has suffered a serious injury while on this drug, please call us immediately for a consultation. There is no charge to discuss this matter and the call is toll free: 1-888-841-9623.