Tablets & Capsules

TC0717

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Tablets & Capsules July 2017 9 demonstrate that the reformulated product would reduce abuse and it was not allowed to make that claim in its marketing materials. This is the first time the FDA has sought to remove a marketed opioid pain medication from sale due to the public health conse- quences of abuse. If Endo declines the FDA's request, the Agency can take legal action to force it to do so. FDA approves first generics of Truvada, Lialda, and Strattera SILVER SPRINGS, MD—The FDA approved the first generic version of Gilead's Truvada (emtricitabine and tenofovir disoproxil fumarate), manu- factured by Teva. The tablets are for the treatment of HIV-1 in combina- tion with other antiretroviral agents. The Agency also approved the first generic of Shire's Lialda (mesalamine). Zydus will manufacture the delayed- release tablets, which are used in treat- ing remission in adults with active, mild to moderate ulcerative colitis. The FDA also approved the first generic versions of Lilly's Strattera (atomoxetine), which treats ADHD in pediatric and adult patients. They will be manufactured by Apotex, Teva, Aurobindo, and Glenmark. Granules Pharmaceuticals to expand Virginia site CHANTILLY, VA—Granules Pharmaceuticals, a subsidiary of Granules India, Hyderabad, India, plans to expand its pharmaceutical R&D and manufacturing capabilities at its 100,000-square-foot facility here. This expansion is expected to create 102 jobs. Briefly noted… AstraZeneca agreed to sell to Grünenthal the global rights to Zomig (zolmitriptan) outside Japan. Zomig is indicated for the acute treatment of migraines and cluster headaches. The rights were previously licensed to Impax Pharmaceuticals. The FDA approved Vertex Pharmaceutical's Kalydeco (ivacaftor) to treat cystic fibrosis in patients age 2 and older who have one mutation in the CFTR gene that is responsive to treatment. The FDA approved Isentress HD (raltegravir) once-daily add-on treat- ment for patients with HIV-1 infection who are currently taking other anti- retroviral agents and have never under- gone treatment for HIV or whose virus has been suppressed on Isentress 400. Follow us on Twitter @TabletsCapsules WHAT WE DO WHAT WE ARE CAPSULES ARE THE VERY ESSENCE OF QUALICAPS ® REDISCOVER QUALICAPS ® at www.qualicaps.com Quali-G™ capsules, the market standard solid dosage form. 100% bovine bone PREMIUM 100% automatic camera inspection QUALICAPS ® INNOVATION Inhalation grade QUALICAPS ® INNOVATION Pharmaceutical Grade Preservative Free QUALICAPS ® INNOVATION We are uniquely positioned to oer a capsule designed and manufactured for optimal performance in pharmaceutical solid oral drug delivery, together with a team of scientific and technical experts at your service.

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