Issue link: https://www.e-digitaleditions.com/i/276262
6 March 2014 Tablets & Capsules industry news Retrophin to buy Manchester Pharma NEW YORK, NY—Retrophin agreed to acquire Manchester Phar - maceuticals, Fort Collins, CO, for $62.5 million. Manchester manufac- tures Chenodal (chenodiol) tablets, which shrink or dissolve gallstones in people for whom surgery poses high risk, and Vecamyl (mecamylamine) tablets that treat hypertension. California's track-and-trace law nullified after DQSA SACRAMENTO, CA—The State of California released a public notice that, upon passage of the federal Drug Quality and Security Act (DQSA) in November 2013, its own proposed e-pedigree legislation with serialization provisions is pre-empted and thus "inoperative" and "inactive." FDA seeks input on future PBPK legislation SILVER SPRING, MD—Pursuant to provisions of the FDA Safety and Innova tion Act, which increases the regulatory powers of the FDA, the Agency is consulting with industry and academic experts on physiologically based pharmacokinetic (PBPK) model- ing within the framework of drug development. The FDA is holding a public workshop in March on the topic and requests comments by April 10. USP acts on elemental impurities, proposes probiotic monograph ROCKVILLE, MD—The US Pharmacopeial Convention (USP) approved section 5.60.30 of General Chapters <232> Elemental Impuri - ties—Limits and <2232> Elemental Contaminants in Dietary Supple - ments, with an official implementa- tion date of December 1, 2015. Also, USP is posting revisions to General Chapters <232> and <233> Elemen - tal Impurities—Procedures to its Pharmacopeial Forum website with a comment deadline of May 31, 2014. In other news, USP proposed the first-ever monograph for a probiotic USA +1 973 467 8140 CAN +1 514 667 6777 UK +44 (0)1782 597540 BB-1243 SCREEN DISASSEMBLE RAPIDLY, AND SANITIZE MANUALLY OR IN AN AUTOCLAVE SMALL BATCH QUICK-CLEAN SIFTERS SCALP MATERIAL LOADED INTO PROCESS EQUIPMENT, CONTAINERS OR VESSELS PORTABLE BATCH SIFTERS BULK PHARMACEUTICALS AND NUTRACEUTICALS 5 SPECIALIZED WAYS SCALP OR DEDUST, THEN CLEAN OR STEAMINPLACE, OR DISASSEMBLE IN MINUTES C.I.P/S.I.P. VIBRATORY SCREENERS BATCH OR INLINE CENTRIFUGAL SCREENERS SLIDE INTERNALS FREELY FROM THE DISCHARGE END OF CANTILEVERED SHAFT FOR SANITIZING BAG DUMP VIBRATORY SCREENERS REMOVE BAG SCRAPS AND OTHER OVER SIZE MATERIALS DUSTFREE • Contamination-free • Sealed, dust-tight systems • Crevice-free designs • Highest sanitary standards • Virtually zero residual • Fast, thorough wash down • Capacities from grams to tons/h • Batch or continuous • Standard and highly custom designs bacterium, Bacillus coagulans, for inclusion in its Food Chemicals Codex. Comments can be posted to The FCC Forum's website through March 31. CRN adds members WASHINGTON, DC—The Coun - cil for Responsible Nutrition dietary supplement trade association added 14 companies to its membership ros- ter in January. New voting member companies include Pacific Nutri - tional, Vancouver, WA. Review article: Most nutrient research flawed BASEL, Switzerland—Most clini- cal trials of vitamin supplements suf- fer from flawed methodology, ren- dering any conclusions on health effects—positive or negative— "unsubstantiated," according to an article in the journal, Nutrients. FDA's Hamburg travels to India, commits to more overseas inspections NEW DELHI, India—FDA Commissioner Margaret Hamburg traveled to India for a roundtable conference, during which she reiter- ated the Agency's plan to increase quality inspections of overseas facili- ties to ensure consumer safety in the USA and around the world. Her comments appeared at blogs.fda.gov. Briefly noted… The FDA approved Farxiga (dapaglioflozin) to treat type 2 dia- betes. It was developed by Bristol- Myers Squibb in partnership with AstraZeneca and will be available in 5- and 10-milligram tablets. Mayne Pharma USA, Paramus, NJ, agreed to purchase the pain- reliever brands Esgic and Lorcet from Forest Laboratories, New York, NY. Mayne acquired the Zebutal brand from Shionogi in November. The FDA approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with inoperable and/or late-stage melanoma. Both tablets are made by GlaxoSmithKline, Research Triangle Park, NC. b-TOCFN_1-7_Masters 3/5/14 10:02 AM Page 6