Since then, FDA has approved an NDA for Oxycodone HCl Capsules, 5 mg (NDA No. 200534), an NDA for Oxycodone HCl Oral Solution, 100.
201194 ). . In a notice that will publish in the Federal Register later this week, FDA, citing safety concerns, will announce the Agency’s plans to take enforcement action against all unapproved single-ingredient, immediate-release human drug products containing Oxycodone HCl for oral administration, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. The announced move is part of FDA’s “ Unapproved Drugs Initiative.
Oxycodone Hydrochloride Oral solution What is this medicine? OXYCODONE (ox i KOE done) is a pain reliever. It is used to treat moderate to severe pain.
They need to know if you have any of these conditions: Addison's disease brain tumor.
Side effects that you should report to your doctor or health care professional as soon as possible:
Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date or 90 days after opening the bottle, whichever comes first. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F).
Stand or sit up slowly. You may get drowsy or dizzy when you first start taking this medicine or change doses.
The overall US market for Oxycodone Hydrochloride Oral Solution is $30 million, per IMS Health. Arthur S. Przybyl, President and Chief.
About Oxycodone Hydrochloride Oral Solution.
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SOURCE ANI Pharmaceuticals, Inc.
To view the original version on PR Newswire, visit: http://www.prnewswire.com/news-releases/ani-pharmaceuticals-announces-launch-of-oxycodone-hydrochloride-oral-solution.
Oxycodone Hydrochloride Oral Solution 5mg/5mL is an opioid agonist indicated for the management of moderate to severe pain where the use.
Arthur S. Przybyl, President and Chief Executive Officer said, "We are pleased to announce the launch of our first internally-developed generic product in the area of pain management, the first of four products we plan to launch before the end of 2015, including Vancomycin Capsules, Nimodipine Capsules, and Flecainide Tablets. The development, manufacturing and marketing of controlled substances represents a strategic focus for ANI and our pipeline includes several additional products in this category.".
More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as its proxy statement.
“Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, is an important and long awaited addition to our pain management franchise.
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“Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, is an important and long awaited addition to our pain management franchise and represents our fourth product approved by the FDA thus far in 2014,” said Arthur P. Bedrosian, president and chief executive officer of Lannett. “We expect to launch the product shortly.”.
Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, the therapeutic equivalent to the reference listed drug, Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, of Lehigh Valley Technologies, Inc. (NYSE: LCI ) today announced that it has received approval from the U.S. Lannett Company, Inc. According to IMS, annualized sales of Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, at Average Wholesale Price (AWP) were approximay $43 million.
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