the United States Food and Drug Administration ("FDA") has indicated to the Company that it has rescinded its previous requirement that the Company meet newly-imposed conditions for bioequivalence prior to receiving final approval for the Company?s tentatively-approved strengths of its generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules (the ?Product?). The strengths affected include 5 mg, 10 mg, 20 mg and 40 mg. The already-approved 15 mg and 30 mg strengths now in the market are not affected.
IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) just announced the submission of its New Drug Application (NDA) for Rexista, it?s bioequivalent OxyContin product. The application comes a little later than first expected, but it?s now in the bag, and the result could be a game changer for the company. It?s targeting an abuse deterrent approval, and if the agency gives the asset a thumbs up for approval, and couples the approval with an abuse deterrent label, it could attract significant investor attention to IntelliPharmaCeutics. There?s also a strong potential catalyst on a commercialization partner announcement for the drug, meaning at its current valuation of $96 million (and taking into consideration a somewhat muted response to the latest NDA filing, there looks to be some degree of potential for a discount entry.
The FDA is now set to make a decision on Valeant Pharmaceuticals (NYSE:VRX)'s psoriasis drug, Brodalumab, on February 16, 2017. The Market Exclusive Intelligence Team set its sights on uncovering the truth about the delay. If you are invested in the stock, or are trading the event, you won't want to miss what we found.
Intellipharmaceutics Provides Update on FDA Advisory Committees Meeting for Rexista? (oxycodone hydrochloride extended release), an Abuse-Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain