SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Microcap & Penny Stocks : Microcap Kitchen Canadian Stocks -- Ignore unavailable to you. Want to Upgrade?


To: Acton who wrote (16831)9/19/2013 10:51:11 AM
From: Flipper12  Read Replies (2) | Respond to of 49402
 
Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON , Sept. 19, 2013 /CNW/ - Cipher Pharmaceuticals Inc. ( DND.TO) ("Cipher") today announced that its sales and distribution partner, Ranbaxy Laboratories Inc. ("Ranbaxy") has received a Paragraph IV Certification Notice of filing from Watson Laboratories Inc. of an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") for a generic version of Absorica™ (isotretinoin capsules).

Ranbaxy and Cipher intend to vigorously defend Absorica's intellectual property rights and pursue all available legal and regulatory pathways in defense of the product. Absorica is currently protected by two issued patents listed in the FDA's Approved Drug Products List (Orange Book), which expire in September 2021 . Ranbaxy shall take appropriate actions in response to the Paragraph IV notice letter, and FDA approval of the ANDA shall then be governed by the Hatch-Waxman Act.

Absorica was approved by the FDA in May 2012 , and granted a three-year market exclusivity period, which expires in May 2015 .