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News Breaks
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November 16, 2009
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| 08:04 EDT |  | PRX |
| theflyonthewall.com: | Par Pharmaceutical receives final approval to market generic Ultram ER | | Par Pharmaceutical has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER. Ortho-McNeil sells extended-release tramadol tablets under the brand name Ultram ER. Par has been awarded 180 days of marketing exclusivity, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product. Annual U.S. sales of the 100mg and 200mg strengths of Ultram ER are approximately $156 million, according to IMS Health data. Par began shipping tramadol ER to the trade upon approval. :theflyonthewall.com |
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February 8, 2012
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| 09:29 EDT | | PRX |
| theflyonthewall.com: | Intellipharmaceutics targeting 2012 FDA approval of generic Focalin XR | | Intellipharmaceutics' (IPCI) goals for 2012 include: Obtain FDA approval of Intellipharmaceutics' generic version of Focalin XR; File two additional ANDAs with the FDA; Establish additional development/marketing alliances; Schedule a pre-IND meeting with FDA to discuss Rexista oxycodone clinical development plan; Complete manufacturing of clinical batches of Rexista oxycodone; and Initiate Phase I studies using clinical batches of Rexista oxycodone. Note that Intellipharmaceutics' in February the company completed private placement financing, and revenue from the amendment of the existing development and commercialization agreement between the Company and Par Pharmaceutical (PRX) to include additional strengths of Focalin XR generic products. Under the terms of the expanded agreement, Intellipharmaceutics received a cash payment from Par and will continue to receive a share of profits from any future sales of our generic versions of Focalin XR. :theflyonthewall.com |
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February 3, 2012
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| 06:18 EDT | | PRX |
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