Issue link: https://www.e-digitaleditions.com/i/581434
8 October 2015 Tablets & Capsules LOOKING FORWARD Ť VWSUHVHUYDWLYHIUHHIRUPXOD Ť VWSKDUPDFHXWLFDOJUDGHQRQJHODWLQ FDSVXOHRIYHJHWDORULJLQ Ť VWFDSVXOHIRULQKDODWLRQWKURXJK '3,GHYLFHV QUALICAPS ® HAS A STRONG RECORD OF PIONEERING IN NEW FORMS OF DRUG ADMINISTRATION, DEVELOPING CAPSULES WITH FEATURES SO WIDELY ACCEPTED AND TRUSTED AS TO BECOME INDUSTRY STANDARDS. :HFRQWLQXHWRSXVKRQZDUGVLQ WKHFUHDWLRQRIWKHQH[WJHQHUDWLRQ FDSVXOHLQDUHDVVXFKDVELRDYDLODELOLW\ DQGQHZPDWHULDOVFKHPLVWU\ DQGWHFKQRORJLHV :HDUHLPDJLQJQRWRQO\WKHFDSVXOH RIWKHIXWXUHEXWDOVRWKHIXWXUHRI KHDOWKFDUHLWVHOIDQGDUHZRUNLQJ WRZDUGVLWHYHU\GD\ Get to know Qualicaps® at CPhI Madrid stand 9H50 and AAPS booth 1630, and learn about how our 100+ years of history as innovators and pioneers drive us as we collaborate in the future of healthcare. element of toxicological concern; and how to apply a risk-based approach to control elemental impurities in drug products. Cipla to acquire two US generics firms MUMBAI, India—Cipla, India's fourth- largest generics maker, agreed to buy InvaGen Pharmaceuticals, Hauppauge, NY, and Exelan Pharmaceuticals, Lawrenceville, GA, for approximately $550 million in cash. InvaGen has about 500 employees and holds 40 approved ANDAs, markets 32 prod- ucts, and has 30 pipeline products. Its annual capacity is 12 billion tablets and capsules. Exelan's generics business mostly serves the federal government and institutional markets. FDA accepts first NDA for digital "chip-in-a-pill" concept SILVER SPRING, MD—A new drug application (NDA) for a tablet containing a drug product with a built-in digital compliance-tracking device was deemed sufficiently complete by the FDA to war- rant further review. The "smart pill" com- bines Abilify (aripiprazole)—a medica- tion approved to treat schizophrenia, bipolar disorder, and other mental health conditions—with an ingestible electronic micro-sensor, made by Proteus Digital Health, Redwood City, CA. When the tablet is swallowed, the sensor communi- cates with a receiver the patient wears as a skin patch, which, in turn, transmits data to a mobile device for monitoring by healthcare providers. If approved, the technology could improve compliance and prevent medication waste, especially among patients whose conditions may interfere with compliance. FDA OKs spirulina for color coatings ROCKVILLE, MD—The FDA amended its color additive regulations (21 CFR Part 73) to allow the use of spirulina extract in coating formulations for dietary supple- ments and pharmaceutical products. The Agency had previously ruled that extracts of spirulina, sometimes known as "blue- green algae," were generally recognized as safe when used as a blue, green, or pur- ple colorant in candy, chewing gum, ice cream, cereals, and other food items. Until this change—made in response to a petition filed by Colorcon, Harleysville, PA—tablet and capsule manufacturers were limited to using FD&C Blue #1 or FD&C Blue #2, which both require batch safety certification. Briefly noted… The FDA granted orphan drug des- ignation to Xuriden (uridine triac- etate), the first medication approved for hereditary orotic aciduria, a very rare metabolic disorder marked by pediatric anemia, urinary tract obstruc- tion, failure to thrive, and develop- mental delays. Xuriden is administered once daily via oral granules mixed into food, milk, or infant formula. The FDA approved Addyi (flibanserin) to treat generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The product, developed by Sprout Pharmaceuticals, Raleigh, NC and to be marketed by Valeant, Laval, Québec, comes in 100 milligram tablets.