Valeant Pharmaceuticals Announces Approval of Retin-A Micro Microsphere 0.08%
LAVAL, Quebec, Jan. 31, 2014 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) for its Supplemental New Drug Application (sNDA) for Retin-A Micro (tretinoin) Gel microsphere 0.08% for the topical treatment of acne vulgaris.
"We are very pleased that the FDA has approved our new strength of Retin-A Micro® as this gives health care providers and patients a new option for the topical treatment of acne vulgaris," stated J. Michael Pearson, chairman and chief executive officer. "This new strength will provide physicians and patients another effective treatment and should be a welcome alternative to current strengths. We look forward to launching 0.08% Retin-A Micro® in the near future."
Safety Information about Retin-A Micro
Most common adverse reactions are skin pain, pruritus, skin irritation and subcutaneous irritation, pharyngitis and erythema.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
This press release may contain forward-looking statements, including, but not limited to, the launch of Retin-A Micro® (tretinoin) Gel microsphere 0.08%. Forward-looking statements may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target" or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. These forward-looking statements speak only as of the date hereof. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, except as required by law.
Posted: January 2014