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News
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October 8, 2010, Somerset, NJ |
| Novel receives tentative approval for the generic version of Salix Pharmaceuticals, OsmoPrep®/ This first-to-file product is currently in litigation and does not have a determined launch date. |
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June 15, 2010, Somerset, NJ |
| Novel and Salix Pharmaceuticals arrive at settlement with respect to Novel's generic OsmoPrep® product. The parties have agreed to an early entry date for Novel's generic product in 2011. Also, Novel is to contract manufacture brand products for Salix Pharmaceuticals |
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May 26, 2010, Somerset, NJ |
| Novel inks exclusive marketing deal with Perrigo for the pending approval of the generic version of halfLYTELY®. |
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May 15, 2010, Somerset, NJ |
| Novel and Salix Pharmaceuticals settle pending litigation with respect to Novel's generic MoviPrep® product. The parties have agreed to an early date for Novel's generic product in 2011. Also, Novel is to contract manufacture some brand products for Salix Pharmaceuticals. |
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May 15, 2010, Somerset, NJ |
| Novel receives tentative approval for the generic version of Salix Pharmaceutical, MoviPrep®. |
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May 15, 2010, Somerset, NJ |
| Novel receives tentative approval for for generic version of Braintree Laboratories HalfLYTELY®. The first-to-file product is scheduled for final approval on or about September 24, 2010. |
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October 6, 2009, Somerset, NJ |
| Novel receives final approval for the OTC version of MiraLAX®. The product will be marketed through partner International Vitamin Corp (formerly Inverness medical Nutritionals) under multiple customers' private/house labels. |
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September 15, 2009, Somerset, NJ |
| Novel receives tentative ANDA approval for the OTC version of MiraLAX® and plans for day-one launch in early October 2009. |
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June 1, 2009, Somerset, NJ |
| FDA approves Novel ANDAs for GaviLyte-G (first to market generic) and GaviLyte-C, AA rated to GoLYTELY® and Colyte® respectively. GAVIS Pharmaceuticals is marketing and distributing GaviLyte-G and GaviLyte-C. |
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May 27, 2009, Somerset, NJ |
| Novel receives approval from the U. S. Food and Drug Administration for its second ANDA, GaviLyte-N, therapeutic equivalent to the brand NuLytely®. Novel’s new product is being marketed and distributed by GAVIS Pharmaceuticals. http://www.gavispharma.com |
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February 1, 2009, Somerset, NJ |
| Novel completes construction and opens doors to new 40,000 square foot packaging, warehousing and distribution facility. |
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December 8, 2008, Somerset, NJ |
| Novel receives its first ANDA approval from the Food and Drug Administration. |
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September 30, 2008, Somerset, NJ |
| Novel Laboratories takes up a new warehousing facility on same campus. |
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September 8, 2008, Raleigh, NC (MEDICAL PATENT NEWS) -- Salix commences patent infringement litigation against Novel Laboratories |
Salix Pharmaceuticals, Ltd. has announced that Salix Pharmaceuticals, Inc. has filed a lawsuit in the United States District Court for the District of New Jersey against Novel Laboratories, Inc. for infringement of the patent protecting OSMOPREP (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets.
Salix has an exclusive license to the patent protecting OSMOPREP from CDC III, LLC (CDC) for commercialization of OSMOPREP in the United States.
The lawsuit is in response to an Abbreviated New Drug Application (ANDA) filed by Novel with the US Food and Drug Administration regarding Novel's intent to market a generic version of OSMOPREP in the United States prior to the May 18, 2013 expiration of U.S. Patent No. 5,616,346.
Salix has full confidence in the intellectual property rights that protect OSMOPREP. Moreover, Salix intends to use all reasonable means at its disposal to continue to vigorously defend and enforce the intellectual property rights protecting OSMOPREP. |
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July 28, 2008, Somerset, NJ |
| Novel Laboratories, Inc. hires new Vice President of Business Development, Kevin Anderson, formerly of Actavis |
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April 9, 2008, San Francisco (THOMSON FINANCIAL NEWS) -- Salix Pharmaceuticals says Novel Labs files to market generic Moviprep |
Salix Pharmaceuticals Ltd. said Wednesday that Novel Laboratories Inc. has filed an abbreviated new drug application to market a generic version of Moviprep, a product indicated for cleansing of the colon as a preparation for colonoscopy.
In a letter, Novel said the patent for Moviprep, which is owned by Norgine Europe B.V. and licensed by Salix, is invalid and unenforceable. The U.S. patent expires on Sept. 1, 2024.
Raleigh, N.C.-based Salix said it has 45 days to begin a patent infringement lawsuit against Novel that would automatically stay, or bar, the Food and Drug Administration from approving Novel's application for up to 30 months or until a district court decision that is adverse to Salix.
Salix said both it and Norgine have full confidence in the intellectual property rights that protect Moviprep. The companies also said they plan to use all reasonable means to defend Moviprep 'from any and all generic intrusion.'… |
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August 23, 2007, Somerset, NJ (PRIME NEWSWIRE) -- Novel Laboratories, Inc. Files First ANDA Application with the FDA |
| Novel Laboratories, Inc., the generic drug …company … announced the filing of Novel's first Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA). |
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December 6, 2006, Somerset, NJ – Novel Laboratories, Inc. is founded as a specialty pharmaceutical company with industry veteran, Veerappan Subramanian, at its helm. |
