Replies to post #88137 on $heff's $tation of $tocks & $olid DD

[hogfan2]

$IPCI... "FDA rescinds bioequivalence requirement for Intellipharmaceutics' generic Focalin XR
Jul 8 2015, 20:09 ET | By: Douglas W. House, SA News Editor
"Intellipharmaceutics (NASDAQ:IPCI) announces that the FDA has rescinded its requirement that the company must show bioequivalence of its generic Focalin XR (dexmethylphenidate hydrochloride extended-release) capsules in the 5 mg, 10 mg, 20 mg and 40 mg strengths prior to market approval. The firm is unaware of any further action required to receive clearance for its Abbreviated New Drug Application (ANDA) for the product.
This is a welcome reversal for company. On June 18, the agency informed it that bioequivalence would be required."