Issue link: https://www.e-digitaleditions.com/i/446555
to 24 weeks. It is one of four recently approved anti-viral therapies that have gained notoriety for their cost—more than $80,000 per patient. Cure rates are 90 percent or greater. NSF joins manufacturers, retailers to develop standard for supplements, OTCs ANN ARBOR, MI—NSF International and major industry stakeholders established the Global Retailer and Manufacturer Alliance to develop consensus-based standards for dietary supplements, OTC drug products, cosmetics, personal-care products, and medical devices. The group plans to develop a single standard for each product category that combines retailer and regulatory requirements. The goal is to reduce audits and costs while strengthening supply-chain safety and quality. EMA adopts final guidance on phthalate excipients LONDON, UK—The European Medicines Agency issued its final guidance on the use of excipients con - taining phthalates. It specifies the per - mitted daily exposure values for dibutyl phthalate (DBP) and diethyl phthalate (DEHP), commonly used as plasticizers, based on evidence of adverse reproductive and develop mental effects. However, review of the data suggests no such safety risks for hydroxypropyl methylcellulose acetate phthalate (HPMCP), polyvinyl acetate phthalate (PVAP), or cellulose acetate phthalate (CAP), which are commonly used in enteric coatings. [Editor's note: The "Eye on Excipients" column in the April 2014 issue provides details about the safety of substances that have the word "phthalate" in their name.] FDA approves abuse-deterrent label for Pfizer, Purdue opioids SILVER SPRING, MD—The FDA granted approval for Pfizer to use opioid abuse-deterrent labeling on its Embeda, a narcotic analgesic containing morphine sulfate and naltrexone. While clinical studies indicate that the naltrexone component blunts the morphine "high," the FDA has asked the company to conduct post-marketing study to evaluate its real-world efficacy. In related news, the FDA approved abuse-deterrent labeling for Purdue Pharma's Hysingla ER (hydrocodone). The tablet is difficult to crush, break, or dissolve, and forms a thick hydrogel that makes it difficult to prepare for injection. FDA adds 2 years to fixed-dose combo exclusivity SILVER SPRING, MD—The FDA expanded market exclusivity from 3 to 5 years on all fixed-dose combination drug products that contain at least one new active ingredient. In the final guidance released October 10, the Agency said it extended exclusivity because the shorter period delayed the development of new combination therapies. Briefly noted… The FDA granted accelerated approval to AstraZeneca's Lynparza (olaparib) 400- milligram capsules to treat advanced ovarian cancer associated with BRCA gene mutation. The EMA recommended approval of Orexigen Therapeutics' Mysimba (naltrexone-bupropion) tablets to help overweight and obese adults lose weight. The medication is marketed in the USA as Contrave. 8 January 2015 Tablets & Capsules COPERION/KTRON