Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis - 11-Aug-2012
Cosmo Pharmaceuticals received a communication from the Dutch Regulatory Agency (MEB) declining the approval of Cortiment(budesonide with MMX technology), indicated for the induction of remission in patients with active, mild to moderate Ulcerative Colitis. The reasons given for the decline were on the grounds of clinical relevance. Cosmo is awaiting the formal letter to get full disclosure of the reasons for this decision. Santarus has filed the drug as Uceris at the FDA. Ferring have ROW rights licensed from Cosmo except for the US and Japan.
Related News
FDA approves Uceris (Santarus) for mild to moderate Ulcerative Colitis
FDA approve Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis
FDA approves Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis
FDA Advisory Panel recommends Humira (Abbott Labs) for treatment of Ulcerative Colitis
Tofacitinib (Pfizer) success in Phase II study for Ulcerative Colitis
Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis
Simponi(Janssen Biotech) filed at FDA and EMA for Ulcerative Colitis treatment
Simponi (Janssen Biotech) shows positive results in Phase III trial for Ulcerative Colitis
Related Gastroenterology Information
Gastroenterology Clinical Guidelines
Dyspepsia: Managing dyspepsia in adults in primary care
NICEEating disorders, Core interventions in the treatment and management of anorexia nervosa, bulimia nervosa and related eating disorders
NICEGastroenterology Clinical Trials
The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness
Clinicaltrials.gov 13 May 2013Randomized Study Comparing Different Chemotherapy + Immune Therapy on the Pathological Response on Metastases From Colorectal Cancer
Clinicaltrials.gov 07 May 2013Gastroenterology Medical Journal Abstracts
Functional Connectivity of the Default Mode Network and Its Association With Pain Networks in Irritable Bowel Patients Assessed via Lidocaine Treatment
The Journal of Pain 05 June 2013Interpretation and Management of Hepatic Abnormalities in Pregnancy
Clinical Gastroenterology and Hepatology 28 May 2013Gastroenterology Medical Apps
DigAlmanac
£13.99
GI Monitor
Free
Related Gastroenterology Drugs
- TOPAL
- KLEAN-PREP
- LOSEC I.V. INJECTION 40MG
- SENOKOT
- PERINAL
- PREPULSID
- URSODEOXYCHOLIC ACID
- MESTINON TABLETS
- FYBOGEL ORANGE
- INFACOL
- ANUSOL CREAM
- PARIET
- FLETCHERS' ARACHIS OIL
- ESOMEPRAZOLE 40MG GASTRO RESISTANT TABLETS
- TROPERGEN
- MUCOGEL
- MYOTONINE
- IMODIUM PLUS CAPLETS GSL
- FYBOGEL MEBEVERINE
- OMEPRAZOLE 10MG CAPSULES
- MERBENTYL
- FLEET PHOSPHO-SODA
- ALTACITE PLUS
- ASACOL FOAM ENEMA
- ANUGESIC HC CREAM
- QUESTRAN LIGHT (DIARRHOEA)
- DIOCTYL 100 MG CAPSULES
- UBRETID
- COLAZIDE 750MG CAPSULES
- COLPERMIN IBS RELIEF CAPSULES
- FLEET ENEMA
- BUSCOPAN TABLETS
- NORIMODE
- HIDRASEC 100 MG HARD CAPSULES
- PEPCID 20 AND 40 MG TABLETS
- ANACAL
- CYTOTEC TABLETS
- GASTROCOTE LIQUID
- CIMETIDINE 200MG/5ML ORAL SOLUTION
- RESOLOR 2MG FILM-COATED TABLETS
- MICOLETTE MICRO-ENEMA
- DIORALYTE RELIEF (DIARRHOEA)
- DOMPERIDONE (DYSPEPSIA) (GENERIC)
- MANEVAC
- DUPHALAC
- ENTOCORT ENEMA
- PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION
- PRO-BANTHINE
- HIDRASEC INFANT 10MG GRANULES FOR ORAL SUSPENSION
- ENTOCORT CR 3MG CAPSULES
- NUTRIZYM GR
- PROCTOFOAM HC
- ATROPINE (GENERIC-GASTROINTESTINAL)
- COMPOUND MACROGOL ORAL POWDER SUGAR FREE.
- MINTEC OR 0.2ML GASTRO-RESISTANT CAPSULES
- NORMAX
- MAALOX PLUS TABLETS
- COLIFOAM
- LOPERAGEN
- CELEVAC TABLETS 500MG
- MICRALAX
- PROTIUM SOLUTION FOR INJECTION
- DESTOLIT
- NORGALAX
- PROTIUM 40 MG TABLET
- ZANTAC 75 TABLETS
- RANITIDINE 150MG/10ML ORAL SOLUTION
- LOSEC CAPSULES 10MG, 20MG & 40MG
- LOPERAMIDE HYDROCHLORIDE
- XIFAXANTA 200 MG FILM-COATED TABLETS
- MOTILIUM 30MG SUPPOSITORIES
- PYROGASTRONE
- REMICADE
- RESOLOR 1MG FILM-COATED TABLETS
- TAGAMET
- ANTEPSIN TABLETS
- SENNA TABLETS
- ELECTROLADE (DIARRHOEA)
- SCHERIPROCT OINTMENT
- CO-DANTHRAMER CAPSULES AND STRONG CO-DANTHRAMER CAPSULES
- KOLANTICON
- CONSTELLA 290 MICROGRAMS HARD CAPSULES
- SUCRALFATE (GENERIC)
- SALAZOPYRIN
- PEPTO-BISMOL CHEWABLE TABLETS
- ZANTAC INJECTION 50MG/2ML
- LOMOTIL TABLETS
- ALU-CAP
- FAMOTIDINE (GENERIC)
- COLOFAC MR
- ORIGINAL ANDREWS SALTS
- AXID CAPSULES
- KAOLIN AND MORPHINE MIXTURE BP
- PANCREASE
- PENTASA SLOW RELEASE TABLETS 1G
- MAALOX SUSPENSION
- HIDRASEC CHILDREN 30MG GRANULES FOR ORAL SUSPENSION
- SALOFALK
- ASACOL SUPPOSITORIES
- PROTIUM 20 MG TABLET
- EPIRUBICIN HYDROCHLORIDE 2 MG/ML SOLUTION FOR INJECTION OR INFUSION
- REGULAN LEMON/LIME FLAVOUR
- MAALOX PLUS
- UNIROID-HC
- CLIPPER 5MG SUSTAINED RELEASE TABLETS
- DESERIL
- NORMACOL
- PROCTOSEDYL
- RENNIE DUO
- BUDENOFALK
- METOCLOPRAMIDE 5 MG/ML INJECTION
- PICOLAX
- OMEPRAZOLE 20MG CAPSULES
- NORMACOL PLUS
- PEPTO-BISMOL, 17.5MG/ML ORAL SUSPENSION
- DE-NOLTAB
- MAXOLON 10MG TABLETS
- URSOFALK SUSPENSION
- MESALAZINE (GENERIC)
- DULCOLAX TABLETS, 5MG
- OILY PHENOL BP (GENERIC)
- METOCLOPRAMIDE 10MG TABLETS
- ENO
- LACTUGAL
- LOSEC INFUSION 40MG
- CIMETIDINE 200 MG TABLETS BP
- ASACOL MR TABLETS
- CREON 10000 CAPSULES
- ZOTON FASTAB
- BUSCOPAN IBS RELIEF
- COLOFAC TABLETS 135MG
- URDOX 300MG FILM-COATED TABLETS, URSODEOXYCHOLIC ACID 300MG FILM-COATED TABLETS
- PYLORID
- HYDROTALCITE SUSPENSION (GENERIC)
- XYLOPROCT 5%/0.275% OINTMENT
- PANCREX V FORTE TABLETS
- GLYCERIN [GLYCEROL] SUPPOSITORIES
Advert for Healthcare Professionals only