FDA approves new Chantix medication guide
BETHESDA, Md. The medication guide for a new anti-smoking drug has received approval from the Food and Drug Administration.
The FDA on Friday approved the medication guide for Pfizer’s drug varenicline, marketed as Chantix.
An FDA alert from February stated that mental side effects in some patients taking Chantix have included depression, agitation, suicidal thoughts and both attempted and completed suicide.
In light of the side effects, the FDA recommended that Pfizer place safety information under the warnings and precautions sections of the drug’s prescription information. Information about mental side effects appears in the medication guide.
Santen completes Phase III testing of eye drug
NEW YORK Inspire Pharmaceuticals announced Friday a $1.25 million milestone payment from Japan-based company Santen Pharmaceutical for the completion of Phase III testing of the eye drug diquafosol tetrasodium, also known as DE-089. The two companies have a collaborative agreement to develop the drug.
DE-089 is designed to treat such eye-surface diseases as dry eye. Santen expects to file for marketing approval in Japan by June, and also plans to market the drug throughout Asia. Pending approval of DE-089 by regulatory agencies, Santen will market the drug while Inspire will receive royalties on net sales.
New York-based Inspire discovers, develops and commercializes ocular and respiratory drugs. Santen specializes in ocular and anti-rheumatic drugs and had headquarters in Osaka, Japan.
Salix receives FDA approvable letter for Balsalazide colitis treatment
RALEIGH, N.C. Salix Pharmaceuticals has received an approvable letter from the Food and Drug Administration for its ulcerative colitis drug Balsalazide Tablet NDA, the company announced May 16. The drug is designed to treat mild-to-moderate active ulcerative colitis in patients 18 years and older. The disease causes ulcers in the lining of the rectum and colon.
Salix has headquarters in Raleigh, N.C., and specializes in drugs to treat gastrointestinal disorders. The company markets such drugs as Colazal (balsalazide disodium) capsules 750 mg, Xifaxan (rifaximin) tablets 200 mg, Osmoprep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) tablets and Moviprep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution.