Tablets & Capsules

TC0516

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to abuse and recommends studies companies should conduct to demonstrate that generic opioids are no less abuse-deterrent than the branded product. Gilead gains FDA approval for Descovy FOSTER CITY, CA—The FDA approved Gilead's Descovy (emtric- itabine, rilpivirine, and tenofovir alafenamide) as an HIV-1 treatment for patients age 12 or older. The tablet, Gilead's third tenofovir alafe- namide-based treatment approved by the Agency, can be taken in combi- nation with other antiretroviral agents or as a once-daily regimen to treat HIV-1. Sun Pharma acquires 14 prescription brands in Japan MUMBAI, INDIA—Sun Pharm - aceutical acquired 14 prescription brands from Novartis in Japan, which will continue to distribute the brands until transferring all marketing autho- rizations to Sun. Teva launches generic Campral JERUSALEM, ISRAEL—Teva Phar - maceutical launched its generic equiva- lent of Campral (acamprosate calcium) in the USA. Treatment with acam- prosate calcium delayed-release tablets helps people abstain from alcohol and is to be used in conjunction with coun- seling and support. Briefly noted… Pfizer and Allergan agreed to ter- minate their merger. According to Pfizer, the decision was driven by a US Department of Treasury decision that makes it more difficult for com- panies to do corporate tax inversions. OSHA issued a final rule to limit workers' exposure to respirable crys- talline silica. This does not apply to the manufacture, final products, or end use of synthetic amorphous sil- ica, which is used as an excipient. Bristol-Myers Squibb, New York, NY, acquired Padlock Therapeutics, Cambridge, MA. The company is working with protein peptidyl argi- nine deiminase inhibitors to develop treatments for rheumatoid arthritis and other autoimmune diseases. 8 May 2016 Tablets & Capsules Draft Guidance addresses abuse deterrence for generic opioids SILVER SPRINGS, MD—The FDA issued a draft Guidance, "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products." It fol- lows a final Guidance about brand- name opioids that the Agency issued in April 2015. The draft Guidance encourages the industry to develop pain medicines that are more difficult Start your FREE subscription at our website: www.tabletscapsules.com. Nilfisk products support your entire solid dose manufacturing process. From the clean-up of dry ingredients during mixing to conveying powders, granules and capsules to containing dust during filling and compacting. See us at INTERPHEX Booth #2637 Solutions for a safe, pure and effective environment Containment • Collection • Conveying www.pharmaceuticalvacuum.com TOTAL DUST CONTROL FOR PHARMACEUTICAL SUITES

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