Tablets & Capsules

TC0318

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10 March 2018 Tablets & Capsules drug development and manufacturing processes. The goal of the program is to provide OPQ staff with a more in-depth understanding of the p h a r m a c e u t i c a l i n d u s t r y , i t s operations, and the challenges impacting a drug's development and commercial life cycle. During site visits, 15 to 20 OPQ staff members will observe the operations of commercial manufacturing plants, pilot plants, and testing operations for 1 to 2 days. Companies that develop and manufacture APIs and drug products are encouraged to contact the CDER OPQ about participation. Walmart offers free opioid disposal product BENTONVILLE, AR—Walmart is now offering DisposeRx, a no-cost opioid disposal product, at all of its 4,700 pharmacies. The product consists of a packet containing ingredients that, when emptied into a tablet or capsule bottle along with warm water, sequester the drug products into a nondivertible and biodegradable gel, allowing patients to responsibly dispose of unused medications in the trash. Patients filling any new Class II opioid prescription at a Walmart pharmacy will receive a free DisposeRx when p i c k i n g u p t h e i r p r e s c r i p t i o n . Walmart will offer patients with chronic Class II opioid prescriptions a free packet every six months. Existing pharmacy patients can also request a free packet at any time. Healthcare organizations, VA form not-for-profit generic drug manufacturer SALT LAKE CITY, UT—Not-for- profit and faith-based healthcare organizations Intermountain Health- care, Ascension, SSM Health, and Trinity Health have consulted with the US Department of Veterans Affairs to form a not-for-profit generic drug manufacturer to make essential generic p r o d u c t s m o r e a v a i l a b l e a n d affordable. The company will directly m a n u f a c t u r e g e n e r i c d r u g s o r s u b c o n t r a c t m a n u f a c t u r i n g t o reputable contract manufacturing organizations. The five organizations represent more than 450 US hospitals. Briefly noted… The FDA approved Trulance (plecanatide) to treat chronic idiopathic constipation in adults. It's manufactured by Synergy Pharmaceuticals, New York, NY. T h e a g e n c y a l s o a p p r o v e d A s t r a Z e n e c a P h a r m a c e u t i c a l s ' Lynparza (olaparib tablets) for treatment of patients with certain types of breast cancer in cases where the tumors have spread or have a specific inherited genetic mutation. It is the first PARP inhibitor approved to treat breast cancer as well as the first drug product approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation. Finally, Avion Pharmaceuticals, Alpharetta, GA, received FDA approval for Balcotra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets), an oral contraceptive product.

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