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This US FDA tentative approval has been awarded for an expanded label for ARYMO ER (morphine sulfate) extended-release (ER) tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Similarly, the sources said for Phase-II 1,419 employees got registered themselves for Category-one, 5,484 applicants for C-II, 12,269 for C-III, 8,831 for C-lV and 18,641 applications were received for C-V.
Results: Median nerve latency was significantly higher, amplitude and velocity were significantly lower in C-I and C-II groups as compared to controls (p less than 0.
In Group C-II ten patients with end stage renal failure not dialyzed yet or have refused dialysis were included.
Males were 57% in control group, 50% in C-I group and 30% in C-II group (p=0.
From the above discussion we felt that the probable diagnosis of the child would be Familial Chylomicronemia / Hypertriglyceridemia which could be either due to LPL deficiency or Apo C-II deficiency.
Oxycodone HCl is the generic version of Purdue's OxyContin C-II tablets, a narcotic analgesic treatment of moderate to severe pain for patients needing round-the-clock analgesic for an extended period.
spontaneum had A-I, A-II, B-I, B-Ia, B-II, and C-II six major types, which is one more than the five major types in cultivated barley.
By contrast, most of the B-I and C-II type accessions were covered spring habit barley with West type brittleness.
Pharmaceutical company Egalet (NasdaqGM:EGLT) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for ARYMO ER tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
According to the company, ARYMO ER (morphine sulfate) extended-release (ER) tablets C-II has been approved in three dosage strengths: 15 mg, 30 mg and 60 mg.
Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of oxycodone HCl controlled release tablets C-II in 10, 20, 40 and 80 mg strengths will be delayed; changing market conditions; the results of new or changed regulations regarding authorized generics; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission.