Subscribe to RSS
Teva Admits Gianvi Label Information was False: Bayer
WATCH OUT — GIANVI IS YAZ
Bayer Sues Teva — Teva Sues Bayer – Find Another Birth Control Pill —- PLEASE.
YOUR LIFE HAS VALUE — FIND ANOTHER BIRTH CONTROL PILL
THERE ARE SO MANY — WHY TAKE YAZ, YASMINE, OCELLA OR GIANVI???
AND NOW THIS:
Teva admits Gianvi label information was false: Bayer
17 June 2010
- Teva to correct label information: Bayer
- Teva has provided FDA with corrected info
June 17 (Reuters) – Bayer said Teva’s U.S. unit admitted in a court proceeding on Wednesday that some of the information included on packages of its oral contraceptive Gianvi was false and agreed to correct its labeling.
Bayer said Gianvi, a generic version of Bayer’s YAZ birth control pill sold in the United States, falsely claimed that it contained Bayer’s technology that extended the shelf life of the drug.
Teva will inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label, Bayer said in a statement.
Teva has already provided the U.S. Food and Drug Administration with the corrected information and has also corrected the labeling of the drug on its U.S. website, Bayer said.
Teva Admits to Making False Statements in US Gianvi™ Label and Agrees to Corrective Measures; – Bayer’s lawsuit under the Federal False Advertising Act (the Lanham Act) results in Teva agreement to make three months of weekly communications to pharmacists to correct false labels
Teva Pharmaceuticals USA Inc. admitted that the Physician Prescribing Information included with packages of its oral contraceptive Gianvi™, falsely claimed that the ethinyl estradiol in the product was stabilized by Bayer’s patented “betadex as a clathrate” formulation, and in fact, that Gianvi does not have Bayer’s patented stabilization formulation. Gianvi is Teva’s product and is sold as a generic version of Bayer HealthCare’s leading oral contraceptive YAZ® (drospirenone & ethinyl estradiol).
17 June 2010
PR Newswire (U.S.)
WAYNE, N.J., June 17 /PRNewswire/ — In a June 16, 2010 proceeding before Judge Virginia Kendall in US Federal Court in the Northern District of Illinois, Teva Pharmaceuticals USA Inc. admitted that the Physician Prescribing Information included with packages of its oral contraceptive Gianvi™, falsely claimed that the ethinyl estradiol in the product was stabilized by Bayer’s patented “betadex as a clathrate” formulation, and in fact, that Gianvi does not have Bayer’s patented stabilization formulation. Gianvi is Teva’s product and is sold as a generic version of Bayer HealthCare’s leading oral contraceptive YAZ® (drospirenone & ethinyl estradiol).
In response to Bayer’s motion for a temporary restraining order and at the end of the hearing before Judge Kendall on the motion, Teva agreed to correct the false label by sending weekly e-mail or fax messages to US pharmacists nationwide for a period of three months. The e-mail or fax messages to pharmacists will provide corrected Physician Prescribing Information that removes the false claim that the ethinyl estradiol in Gianvi is stabilized by betadex as a clathrate and calls the pharmacist’s attention to this corrective label change.
Teva also agreed not to ship any additional Gianvi product containing promotional materials, package inserts or any other material falsely claiming that the ethinyl estradiol in Teva’s Gianvi is stabilized by betadex as a clathrate. Teva reported that it has already provided the US Food and Drug Administration (FDA) with corrected Physician Prescribing Information for Gianvi and that it has corrected the Gianvi label information on the Teva USA website.
Finally, Teva agreed to send, by e-mail or fax, the corrected Physician Prescribing Information to all known wholesalers, distributors and chain retailers that received Gianvi, and direct them to the label change.
As a result of Teva’s agreement to take measures Bayer requested in its emergency motion, the Court denied Bayer’s motion for a temporary restraining order without prejudice as moot. Teva was ordered by Judge Kendall to file a compliance report on its progress on these actions by 5:00 pm on Friday, June 18, 2010.
Bayer is pleased with the Court’s decision and is committed to vigorously enforcing its intellectual property. Bayer has also filed suit against Teva for patent infringement in the states of Delaware and Nevada.
About Use of Betadex as a Clathrate
YAZ contains drospirenone and ethinyl estradiol. In YAZ, the ethinyl estradiol is enclosed within a beta-cyclodextrin (betadex) clathrate. A clathrate is a molecule that forms a “cage” around another molecule or molecules. The betadex clathrate in YAZ is a Bayer-patented technology that protects the enclosed ethinyl estradiol molecule and stabilizes the product against oxidation. This patented technology enhances the product’s shelf life.
About YAZ®
YAZ (drospirenone & ethinyl estradiol) is indicated for:
* The prevention of pregnancy in women who elect to use an oral contraceptive.
* Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception.
* The effectiveness of YAZ for PMDD when used for more than 3 menstrual cycles has not been evaluated. YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).
* Treatment of moderate acne vulgaris
* In women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of moderate acne only if the patient desires an oral contraceptive for birth control.
Important Safety Information About YAZ
Who Shouldn’t Take Any Oral Contraceptives (OCs)? Some women should not use OCs, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.
In Addition, Who Shouldn’t Take YAZ? YAZ each contain drsp®, a different kind of hormone that for some may increase potassium too much. Therefore, you should not take YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Tell your doctor if you are on daily long-term treatment for a chronic condition such as cardiovascular disease or chronic inflammatory disease. Women who take certain drugs (see below) should have their potassium levels checked in the first month of taking YAZ.
What Drugs May Increase Potassium? NSAIDs-ibuprofen (Motrin®, Advil®), naproxen (Naprosyn®, Aleve®, and others) when taken long-term and daily for arthritis or other diseases or conditions, potassium-sparing diuretics (spironolactone and others), potassium supplementation, ACE inhibitors (Capoten®, Vasotec®, Zestril®, and others), angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®, and others), aldosterone antagonists, and heparin.
What Are The Risks Involved With Taking Any Oral Contraceptive (OC)? OCs can be associated with an increased risk of several serious cardiovascular side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. OCs do not protect against HIV infection or other STDs.
The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were present in all YAZ clinical trials included: upper respiratory infection, headache, breast pain, vaginal moniliasis, nausea, abdominal pain, dysmenorrhea, urinary tract infection, accidental injury, sinusitis, emotional lability, suspicious Papanicolaou smear, weight gain, depression, menstrual disorder, and asthenia.
The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were either unique to each trial type or occurred in only two types of clinical trials included:
In the contraception trial: leukorrhea, diarrhea, vomiting, vaginitis, flu syndrome, moniliasis, allergic reaction, cystitis, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, dyspepsia, rhinitis, acne, gastroenteritis, bronchitis, pharyngitis, skin disorder, intermenstrual bleeding, decreased libido, pain, increased cough, dizziness, pain in extremity, and pelvic pain.
In the PMDD trials: intermenstrual bleeding, decreased libido, nervousness, menorrhagia, pain in extremity, migraine, vaginitis, hyperlipidemia, back pain, diarrhea, increased appetite, enlarged abdomen, and acne.
In the acne trials: metrorrhagia, flu syndrome, menorrhagia, gastroenteritis, tooth disorder, infection, vomiting, pharyngitis, sore throat, arthralgia, bronchitis, rhinitis, amenorrhea, and urine abnormality.
Please see full prescribing information at www.yaz-us.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Teva Files Own Suit Against Bayer On Birth Control Pill
Of DOW JONES NEWSWIRES
2 June 2010
NEW YORK -(Dow Jones)- Teva Pharmaceuticals Industries Ltd. (TEVA) has filed its own lawsuit against a unit of Bayer AG (BAYRY), seeking court confirmation that the generic drug maker’s patents on a birth-control drug are valid.
Teva, in a suit filed in U.S. District Court in Manhattan, said its commercial launch of Gianvi, a generic version of Bayer’s birth-control drug Yaz, doesn’t infringe any patent claim.
Bayer’s pharmaceutical unit, Bayer Schering Pharma, had previously filed a lawsuit saying exactly that in Delaware on Tuesday, arguing any generic of Yaz should be stopped until 2014, when it believes it patent would expire.
Gianvi was approved by the U.S. Food and Drug Administration on March 30, 2009, and Teva said it has the right to launch the drug by July 2011. Teva, along with its subsidiary Barr Laboratories Inc., said it is seeking the court to affirm its patents and stop Bayer’s lawsuit.
A representative for Bayer wasn’t immediately available for comment.
Teva’s release announcing the drug’s launch on Friday said Yaz had $782 million in sales during 2009.
-By David Benoit, Dow Jones Newswires; 212-227-2017; david.benoit@dowjones.com [ 06-02-10 1913ET ]
Reuters reported that Teva Pharmaceuticals Industries Limited asked a U.S. court to resolve a dispute over its unexpectedly swift introduction to the United States of a generic version of Bayer AG’s YAZ birth control pill. Bayer Schering Pharma AG said that it had filed a patent infringement lawsuit against Teva Pharmaceutical Industries Ltd after Teva launched the contraceptive under the brand name Gianvi. Barr Laboratories, a wholly owned subsidiary of Teva, was also named as a plaintiff.
Significant Development ID Number 1905437
Contact an Attorney
Translator
 |  |  |  |  |  |  |  |
 |  |  |  |  |  |  |  |
 |  |  |  |  |  |  |  |
 |  |  |  |  |  |  |  |
 |  |  |  |  |  |  |  |
 |  | ||||||