Stock Update (NASDAQ:IPCI): IntelliPharmaCeutics Intl Inc (USA) Updates Status of Tentative Approvals of Generic Focalin XR(R)


IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today advised that the United States Food and Drug Administration (“FDA”) has indicated to the Company that it has rescinded its previous requirement that the Company meet newly-imposed conditions for bioequivalence prior to receiving final approval for the Company’s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.

The FDA, in November 2013, had previously granted the Company tentative approvals for the 5 mg, 10 mg, 20 mg, and 40 mg strengths of its generic Focalin XR®. Subsequently, the Company announced in a press release dated June 18, 2015, that the FDA had indicated that the Company would be required to meet newly-imposed guidelines before the affected strengths of the Product could receive final approval. The FDA has now rescinded that requirement.

The Company is not aware of any further action required of it in respect of its Abbreviated New Drug Application (“ANDA”) for the Product. The Company is therefore hopeful that the FDA will shortly grant final approval for the 5 mg strength of the Product which is not subject to the six months of market exclusivity accorded to the first-filer of an ANDA. There can be no assurance that such final approval will be granted within a short time, or at all, or that further conditions will not be imposed for that strength or any of the other tentatively approved strengths. (Original Source)

Shares of Intellipharmaceutics closed today at $2.84, down $0.01 or 0.35%. IPCI has a 1-year high of $3.92 and a 1-year low of $1.94. The stock’s 50-day moving average is $3.16 and its 200-day moving average is $2.71.

On the ratings front, Intellipharmaceutics has been the subject of a number of recent research reports. In a report issued on May 26, Maxim Group analyst Jason Kolbert maintained a Buy rating on IPCI, with a price target of $7, which implies an upside of 146.5% from current levels. Separately, on May 21, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $8.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Jonathan Aschoff have a total average return of -0.8% and 11.4% respectively. Kolbert has a success rate of 36.9% and is ranked #3069 out of 3692 analysts, while Aschoff has a success rate of 56.3% and is ranked #183.

IntelliPharmaCeutics International Inc is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs.