investigational product

investigational product

A test article or pharmaceutical form of an active ingredient or placebo that is tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, used for an unapproved indication, or used to gain further information about an approved use.
References in periodicals archive ?
The United States Food and Drug Administration (FDA) has granted Fast Track designation to Emalex Biosciences Inc, a US-based biopharmaceutical company, for its investigational product, Ecopipam, intended for the treatment of patients with Tourette Syndrome (TS), it was reported yesterday.
Axcella announced the publication of data describing the safety, tolerability and impact of investigational product AXA2678 on short-term muscle disuse atrophy in young healthy men.
Key product candidates in this category include POSIMIR (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery, a long-acting injectable SABER-based HIV investigational product being developed with Gilead and ORADUR-Methylphenidate ER Capsules, approved in Taiwan as Methydur Sustained Release Capsules, where it is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).
Originally developed by Elcelyx Therapeutics, Metformin DR is an investigational product designed to target metformin delivery to the lower small intestine.
HOPE-2 will test the company's lead investigational product, CAP-1002 in DMD.
is the manufacturer of the investigational product and oversaw the trial and manuscript preparation as the sponsor."
In addition, it must ensure that each investigational product has the same appearance, even in transparent syringe barrels.
Zogenix's lead investigational product candidate, Zohydro ER (hydrocodone bitartrate extended release capsules), is an oral, extended-release formulation of various strengths of hydrocodone, without acetaminophen, intended for administration every 12 hours for around the clock management of moderate to severe chronic pain.
The transaction was agreed in May for an initial payment of USD323m, or USD12.70 a share in cash, and contingent value rights (CVRs) of around USD120m, or USD4.70 a share, subject to certain milestones related to Omtheraa[euro](tm)s investigational product Epanova or global net sales being achieved, the buyer said.
The company plans to use the funds raised through the issue for the repayment of all amounts outstanding under its amended and restate loan and security agreement with Oxford Finance LLC and Silicon Valley Bank, for the financing of the pre-approval and pre-commercialisation activities of its lead investigational product candidate Zohydro ER, for the ongoing commercialisation of its first commercial product Sumavel DosePro as well as for working capital and other general corporate purposes.
VicCell, Inc., Cambridge, MA, announced the FDA has conditionally approved its Investigational Device Exemption (IDE) to evaluate its ViaCyte investigational product offering for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology.

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