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from Pharma Times by Selina McKee US regulators have asked that Shire include paediatric data in its resubmission of SHP 465 for attention-deficit hyperactivity disorder, throwing yet another obstacle in its bid for approval. SHP 465 (formerly SPD465) has the same active ingredient as the firm’s Adderall XR (mixed amphetamine salts) but is designed to […]
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from by: Randi Hernandez Hospira announced on Oct.1, 2014 that it received a warning letter from FDA regarding its manufacturing plant in Mulgrave, Australia. In the letter, FDA reprimanded the manufacturer for not addressing “significant violations of current good manufacturing practice” the agency observed earlier in the year. According to FDA, Hospira failed to […]
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