Healthcare Industry News: Barr Laboratories
News Release - August 13, 2012
Teva Receives FDA Acceptance of Its New Drug Application for Quartette(TM) (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for the Prevention of Pregnancy
First Ascending-Dose Extended Regimen Oral Contraceptive Designed to Decrease Breakthrough Bleeding Between Scheduled PeriodsFRAZER, Pa.--(Healthcare Sales & Marketing Network)--Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for Quartette™ (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets). The company is seeking approval to manufacture and market Quartette™, the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy. The NDA was submitted to the FDA on May 31, 2012.
The submission was based on a clinical development program including results from Phase I, Phase II, and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette™ in the prevention of pregnancy. The clinical trials involved more than 3,000 female subjects.
“Quartette™ is an ascending dose regimen oral contraceptive intended for prevention of pregnancy. We looked at when and why breakthrough bleeding occurs and designed Quartette™ to have less disruptive, unscheduled bleeding,” said Nancy Ricciotti, senior director of clinical affairs, Teva Women's Health R&D. “Quartette builds upon our heritage in providing women with innovative, extended-cycle contraceptive products and we look forward to the potential to offer the first ascending-dose extended regimen birth-control option.”
Women may experience breakthrough bleeding (BTB) with any birth control pill, especially during the first few months. Numerous studies of extended regimens have shown that unscheduled BTB often increases typically during the first few months of treatment.i,ii,iii,iv BTB is one of the reasons a large number of women discontinue extended regimens.i,ii,iii,iv,v,vi,vii
Quartette™ is a trademark of Barr Laboratories, Inc.
About Teva
Teva Pharmaceutical Industries Ltd. (TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.
Teva’s Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: The following discussion and analysis contains forward-looking statements, which express the current beliefs and expectations of management. Such statements involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition from the introduction of competing generic equivalents and due to increased governmental pricing pressures, the effects of competition on sales of our innovative medicines, especially Copaxone® (including competition from innovative orally-administered alternatives as well as from potential generic equivalents), potential liability for sales of generic medicines prior to a final resolution of outstanding patent litigation, including that relating to our generic version of Protonix®, the extent to which we may obtain U.S. market exclusivity for certain of our new generic medicines, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), our ability to achieve expected results through our innovative R&D efforts, dependence on the effectiveness of our patents and other protections for innovative medicines, intense competition in our specialty pharmaceutical businesses, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based medicines, our potential exposure to product liability claims to the extent not covered by insurance, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, adverse effects of political instability and adverse economic conditions, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, the impact of continuing consolidation of our distributors and customers, the difficulty of complying with U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority requirements, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, the termination or expiration of governmental programs or tax benefits, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2011, in this report and in our other filings with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update any forward-looking statements or other information contained in this report, whether as a result of new information, future events or otherwise. You are advised, however, to consult any additional disclosures we make in our reports to the SEC on Form 6-K. Also note that we provide a cautionary discussion of risks and uncertainties under “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2011. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those listed could also adversely affect us. This discussion is provided as permitted by the Private Securities Litigation Reform Act of 1995.
i Loudon NB.etal.BM7. 1977;2:487-90.
ii Kwiecien M, et. al. Contraception. 2003;67:9-13.
iii Miller Land Hughes JP. Obstetrics & Gynecology. 2003;101:652-61.
iv Sulak PJ, etal. Obstetrics & Gynecology. 1997;89:179-83.
v Seasonique Prescribing Information.
vi LoSeasonique Prescribing Information.
vii Archer DF, et al. Contraception. 2006: 74; 439-445.
Source: Teva Pharmaceutical
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