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 announced that the United States Food and Drug Administration (“FDA”) has indicated that the Company’s tentatively-approved strengths of its generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules (the “Product”) will have to meet newly-imposed conditions for bioequivalence prior to receiving final approval. The strengths affected are 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®. The Company is now required by the FDA to demonstrate bioequivalence with Focalin XR®, under the new bioequivalence criteria, for the 40 mg strength as a basis for the approval of each of the affected strengths.
The Company, together with its United States commercialization partner, Par Pharmaceutical, Inc., intends to review and vigorously pursue all reasonable courses of action towards achieving final approval for each of the affected strengths. There can be no assurance that the affected strengths of the Product will be granted final FDA approval or sold commercially. (Original Source)
Shares of Intellipharmaceutics closed today at $3.45, up $0.05 or 1.47%. IPCI has a 1-year high of $4.19 and a 1-year low of $1.94. The stock’s 50-day moving average is $3.17 and its 200-day moving average is $2.68.
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 represents a potential upside of 102.9% from where the stock is currently trading. 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 2.6% and 10.5% respectively. Kolbert has a success rate of 41.8% and is ranked #1250 out of 3632 analysts, while Aschoff has a success rate of 53.2% and is ranked #273.
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.