The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SYMPROIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Sandoz announces that it has signed an agreement with Shionogi & Co Ltd for commercialization of Rizmoic (naldemedine) in the key European markets of Germany, the UK and the Netherlands, plus right of first refusal for certain other European markets.
Shionogi NV`s Rizmoic (Naldemedine tosilate) Receives Approval in Europe
Nearly two years after winning US approval for its opioid-induced constipation drug, Japan’s Shionogi has secured the European nod for the treatment, naldemedine, in patients that have been previously treated with a laxative.
OSAKA, Japan & FLORHAM PARK, N.J. & STAMFORD, Conn.--(BUSINESS WIRE)--Shionogi Inc. and Purdue Pharma L.P. today announced the publication of a study known as COMPOSE-3. The study is the first to investigate a peripherally-acting mu-opioid receptor antagonist (PAMORA) over the course of 52 weeks in a randomized, placebo-controlled and double-blind manner. The study was published online ahead of print in PAIN, the journal of the International Association for the Study of Pain.
OSAKA, Japan & FLORHAM PARK, N.J. & STAMFORD, Conn.--(BUSINESS WIRE)--Shionogi Inc. and Purdue Pharma L.P. announced today that Symproic® (naldemedine) 0.2 mg tablets are now available throughout the United States. The U.S. Food and Drug Administration (FDA) approved Symproic as a once-daily oral tablet for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.