In Brief
This article was originally published in The Tan Sheet
Executive Summary
Perrigo launches Aleve generic
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Perrigo launches Aleve generic The private labeler says it appears to be first to market with a generic version of Bayer's Aleve Liquid Gels pain reliever/fever reducer. Allegan, Mich.-based Perrigo said Nov. 29 the branded naproxen sodium 220-mg capsules are worth $80 million in sales to Bayer, which introduced Aleve Liquid Gels in 2007 ("New Aleve formulation," "The Tan Sheet" March 19, 2007, In Brief). A spokesman said Perrigo will offer a range of pack sizes for its Naproxen Sodium Soft Gels. US Farms, Phytoceutical join forces A partnership between US Farms Inc., the marketer of Aloe365 brand products, and Phytoceutical Inc. will yield a pair of new products in 2011. US Farms said Nov. 29 it will market a Phytoceutical product based on the epilobium herb to support prostate health at a suggested retail price of $24.95 for 4 ounces. Epilobium is used in traditional medicine for its antibacterial, anti-inflammatory and antioxidant properties. The San Diego-based companies also will team on a private-label aloe product. Ella Rx launch in U.S. competes with OTCs The emergency contraceptive ella (ulipristal acetate 30 mg) is available in the U.S., Watson Pharmaceuticals says Dec. 1. The Morristown, N.J., firm plans physician and consumer education on ella, which helps prevent pregnancy up to five days after intercourse. Rx ella could compete with nonprescription Plan B One-Step from Teva and Watson's own Next Choice ("EC competition clears advisory panel," "The Tan Sheet" June 21, 2010, In Brief). Watson said an eventual OTC switch is possible for ella, which has market exclusivity until Aug. 13, 2015, according to FDA's Orange Book. POM Wonderful suit is "moot" – FTC The Federal Trade Commission argues it has not instituted a new claims substantiation rule, as alleged in a complaint filed by POM Wonderful, and the firm's lawsuit should be dismissed. The maker of pomegranate juices and supplements claimed in a Sept. 13 lawsuit that FTC raised its claim substantiation standards, but the agency has published no formal rule. In a motion to dismiss filed Nov. 16 in the U.S. District Court for the District of Columbia, FTC argues POM's complaint is moot. It says the company has no standing as it has not been injured and POM's suit is an attempt to interfere with an enforcement action, which FTC filed against POM Sept. 27 (Also see "POM Wonderful Defends Its Claims, Says FTC Action Is Persecution" - Pink Sheet, 4 Oct, 2010.). Marketers sentenced for misleading claims Tony Pham and Charles Thao are sentenced to prison for selling online $11.9 million of dietary supplements with illegal claims, says the U.S. attorney's office for the Western District of Missouri. Pham, who owned and operated Techmedica Health Inc. of Grand Rapids, Mich., will serve three years ("Bogus claims found despite evasive tactics," "The Tan Sheet" July 13, 2009, In Brief). Pham pleaded guilty to conspiring to violate the Food, Drug and Cosmetic Act and to launder money. His websites used mirror image technology to display "sanitized" claims when accessed from an FDA Internet Protocol address, the USAO said Nov. 22. Thao, of Springfield, Mo., contracted with Pham and sold supplements via Nutrapha Research LLC and other firms; he was sentenced to eight years and one month in federal prison. CPSC finalizes database rule Three of five commissioners vote for the final rule for the Consumer Product Safety Commission's incident report database, and against an alternate plan supported by the Consumer Healthcare Products Association. CHPA and other industry groups worry the Consumer Product Safety Information Database could post inaccurate and unverified product information without giving firms ample opportunity for review (Also see "CHPA Favors Alternate Plan For CPSC Database Covering OTCs, Supplements" - Pink Sheet, 22 Nov, 2010.). CPSC Chairman Inez Tenenbaum says Nov. 24 the database will have "built-in protections." Commissioner Nancy Nord, who proposed the alternate plan, says the majority approach is "poorly conceived and excessive regulation." FDA allows testing of OTC HIV diagnostic FDA granted OraSure Technologies an investigational device exemption to allow the final phase of clinical testing for OraQuick Rapid HIV-1/2 Antibody Test for sale OTC. In this phase, individuals will conduct unsupervised self-testing using the investigational product, the Bethlehem, Pa.-based company says Nov. 22. The company expects enrollment to begin before year's end. |