Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista™ NDA [Canadian Business Journal (Canada)]
INTELLIPHARMACEUTICS (IPCI)
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Source: Canadian Business Journal
Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista™ NDA TORONTO, Sept. 25, 2017 (GLOBE NEWSWIRE) — Intellipharmaceutics International Inc. (Nasdaq: IPCI ) (TSX: IPCI ) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled- and targeted-release oral solid dosage drugs, today provided an update on its Rexista TM , henceforth referred to as Oxycodone Hydrochloride Extended-Release Tablets (“Oxycodone ER”), program. The Company has received a Complete Response Letter (“CRL”) from the United States Food and Drug Administration (“FDA”) for its Oxycodone ER New Drug Application (“NDA”). In its CRL, the FDA provided certain recommendations and requests for information, including that Intellipharmaceutics complete the relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of admi
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