Orexigen looking for FDA approval in next few months, says Cowen Cowen noted Orexigen announced Q4 results last night and provided an update on its regulatory processes. The firm remains positive on Contrave's potential lifecycle management opportunities and reiterates its Outperform rating and $10 price target.
Paragraph IV patent challenges submitted to FDA for Orexigen's Contrave An Abbreviated New Drug Application, or ANDA, has been received by the Office of Generic Drugs containing a "Paragraph IV" patent certification for Contrave, the weight loss drug whose patent is owned by Orexigen Therapeutics, according to an FDA notice. The date on which the first substantially complete generic drug application was submitted to the Agency for Contrave was March 12, according to the posting. Reference Link