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News Breaks
08:04 EDTPRX
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



News For PRX From The Last 14 Days
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February 9, 2010
11:17 EDTPRX
theflyonthewall.com: Par Pharmaceutical volatility elevated as shares trend lower
Par Pharmaceutical is recently down 67c to $24.72. On February 5th PRX announced the FDA stated an inability to approve Zuplenz due to an agency wide restriction on foreign travel to India. PRX is expected to report Q4 EPS on February 24. Call option volume of 609 contracts compares to put volume of 1,146 contracts. February put option implied volatility is at 50, March is at 56 , May is at 51; above its 26-week average of 45, according to Track Data, suggesting larger price movement. :theflyonthewall.com

February 5, 2010
16:48 EDTPRX
theflyonthewall.com: Par subsidiary gets update on Zuplenz new drug application
Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, announced that the FDA issued a complete response letter regarding the new drug application, or NDA, for Zuplenz oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery. Due to an agency-wide restriction on foreign travel in India, the FDA has been unable to perform an inspection of the clinical and analytical sites for a bioequivalence study, and therefore, cannot approve the application at this time.  The FDA advised that they will schedule and perform an inspection of these sites as soon as possible.  Strativa will continue to work with the FDA on completing these site inspections and finalization of product labeling. No issues related to the study data or film product were identified. :theflyonthewall.com
07:19 EDTPRX
theflyonthewall.com: Par Pharmaceutical FDA PDUFA Date for Ondansetron

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January 30, 2010
16:39 EDTPRX
theflyonthewall.com: Weekly additions to the Investor's Business Daily-100

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:theflyonthewall.com