(By Balaseshan) Sucampo Pharmaceuticals Inc. (NASDAQ: SCMP) said it has received a supplement approval from the U.S. Food and Drug Administration (FDA) for updates to Amitiza (lubiprostone) pregnancy labeling.
The approval removes pregnancy "warnings and precautions" and clarifies information regarding the use of Amitiza (lubiprostone) by pregnant and/or nursing women. In addition, the FDA expanded the labeling text of the Mechanism of Action section in the prescribing information for Amitiza.
Amitiza is approved for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older (8 mcg twice daily).
[Related -Top Insider Purchases: ACAD, FCX, CLMS, EPZM, GHDX, SCMP]
The company also said the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency's priority review of the supplemental new drug application (sNDA) filing seeking approval for an additional indication for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
Sucampo was notified that its November 16 submission of FDA-requested supportive analyses has been designated as a major amendment to the application.
Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has decided to extend the goal date by three months to provide time for a full review of the submission. The extended user fee goal date is late April, 2013. No new clinical trials or studies have been requested by the FDA.
[Related -Sucampo (SCMP) Receives FDA Approval Of Snda For Rescula Glaucoma Drops]
SCMP closed Friday's regular session up 2.75 percent at $5.24. The stock has been trading between $3.73 and $8.50 for the past 52 weeks.