Teva obtains FDA approval for oral contraceptive | Janssen submits hepatitis C drug candidate Simeprevir for FDA approval | Novartis will still file patent applications in India
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April 2, 2013
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Teva obtains FDA approval for oral contraceptive
Teva Pharmaceutical Industries has gained FDA approval for its Quartette oral contraceptive tablets to minimize breakthrough bleeding between menstruation cycles. Drug Store News (4/1)
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Janssen submits hepatitis C drug candidate Simeprevir for FDA approval
Janssen Research & Development filed a new drug application with the FDA for approval to use its NS3/4A protease inhibitor Simeprevir, or TMC435, with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. The application was based on results of late-stage trials involving previously untreated and treatment-experienced patients with compensated liver disease. Pharmaceutical Business Review Online (4/1)
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Novartis will still file patent applications in India
Novartis India will still submit patent applications in India despite the country's Supreme Court decision denying the drugmaker a patent for cancer treatment Glivec, Vice Chairman Ranjit Shahani said. The drugmaker also plans to keep investing in the country with caution, Shahani added. Reuters (4/1)
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PhRMA blasts Indian court's ruling against drug patent
The Pharmaceutical Research and Manufacturers of America rebuked India's Supreme Court for refusing to grant Novartis patent protection on its cancer medicine Glivec. The ruling is "another example of what I would characterize as a deteriorating innovation environment in India," said Chip Davis, PhRMA's executive vice president of advocacy. "[I]t is critically important that India promote a policy environment that supports continued research and development of new medicines for the health of patients in India and worldwide," PhRMA CEO John J. Castellani said. The Hill/Healthwatch blog (4/1), The New York Times (tiered subscription model) (4/1), Reuters (4/1)
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Brazil plans to streamline health care product approval
Brazil's health ministry announced plans to speed approval and registration of health care products. Anvisa, the country's health care products regulatory agency, plans to expand its technical staff, open an electronic registration application system for drugs, allow partner agencies to inspect foreign manufacturers and recognize inspections by other agencies or certification bodies. Clinica (subscription required) (3/28)
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Food & Dietary Supplements
Producer of baking mixes pulls products for milk use
Heartland Gourmet has decided to recall cookie mix products, which were distributed in seven states, due to undeclared use of milk. Affected products include 16 ounce-packs of Gluten Free Chocolate Chip Cookie Mix and Gluten Free Double Chocolate Cookie Mix, as well as 15.4-ounce-packs of Gluten Free Pizza Crust Mix. Food Business Review (4/1)
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Medical Devices
Appeals court rules in favor of Abbott in patent suit
A federal appeals court ruled in favor of Abbott in a patent infringement case with Cordis, a Johnson & Johnson unit, regarding drug-eluting stent technology. The court upheld a lower court's decision to nullify two subpoenas sought by Cordis to find proof of its allegation that Abbott copied the stent patents. (Boston) (4/1)
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ChromaGen's lenses for dyslexia gain FDA nod
ChromaGen Vision received federal approval for its ChromaGen lenses, designed to improve reading speed and accuracy as well as handwriting in patients with dyslexia and related conditions. Healio (4/1)
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FDA: Nicotine gum, patch makers can change smoking cessation labels
The FDA announced its decision to allow makers of nicotine gum, patches and lozenges to change labels recommending consumers quit smoking when using nicotine replacement products. Also, the FDA said manufacturers can change labels to say that the products can be used for longer time periods than previously indicated. The agency expects the changes to encourage more consumers to "use these products effectively for smoking cessation and that tobacco dependence will decline," said FDA Commissioner Margaret Hamburg. The Washington Post/The Associated Press (4/1)
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FDLI Items
Don't miss FDLI's spring introductory courses on drug or medical device law and regulation
FDLI's industry standard two-day introductory courses are important programs we have been offering for more than 20 years - teaching thousands to think like seasoned professionals. Whether you are a new professional in the medical device or pharmaceutical industry or a seasoned regulatory affairs or legal professional needing a refresher on current FDA regulatory developments, you will benefit from attending our in-depth, interactive courses. FDLI's introductory courses can help you and your organization understand FDA regulations, support your efforts to get products approved and know when FDA is likely to allege violations of the law.
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Top 20 cases in food and drug law at Annual Conference, April 24
Join us at FDLI’s Annual Conference for one of our most popular plenary sessions, as academic experts review the “Top 20 Cases in Food and Drug Law in 2012 and Cases to Watch in 2013.” Drawing from FDLI’s newest edition of Top 20 Cases, food and drug law professors will discuss the legal and practical impact—on the entire food and drug law community—of 2012’s most sweeping cases and highlight cases to watch in 2013:
  • Bartlett v. Mutual Pharmaceutical
  • Discount City Tobacco v. FDA
  • United States v. Regenerative Sciences, LLC, et al.
  • Weddle v. Bayer AG Corporation
  • Pom Wonderful LLC v. The Coca-Cola Company
A detailed agenda is available online.
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Who's Hiring?
Position TitleCompany NameLocation
Deputy Director, Office of Compliance and EnforcementFood and Drug Administration/ Center for Tobacco ProductsRockville, MD
Senior Compliance CounselMedivation, IncSan Francisco, CA
CounselVerto Solutions, LLCWashington DC, DC
Director, Drug Safety & InnovationThe Pew Charitable TrustsWashington, DC
Associate General Counsel - RegulatoryUCB, Inc.Atlanta, GA
FDA/Healthcare AssociateArnold & Porter LLPWashington, DC, DC
Click here to view more job listings.
If children grew up according to early indications, we should have nothing but geniuses."
-- Johann Wolfgang von Goethe,
German writer, artist and politician
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