MS&D's INDOCIN (INDOMETHACIN) SUPPOSITORIES TRADE PRICE IS $17.74 for a carton of 30, the firm said Sept. 7, the same day that it began distributing the drug. The suppository form of the drug cleared FDA Aug. 14. In announcing the product's availability, Merck stated that it is "the first suppository form of a Rx non-steroidal anti-inflammatory drug (NSAID) for the treatment of certain forms of arthritis." In the announcement Merck maintained that the suppository form provides a more rapid rate of absorption than capsules. Also, Merck said, there is some evidence that adverse gastric side effects may be reduced by the suppository dosing. The company said that the rectal suppositories "are particularly suited as an alternate dosage form for patients who cannot or will not take oral medication, and a supplement (i.e., nighttime) to the capsule form for the management of night pain and morning stiffness associated with rheumatoid arthritis and osteoarthritis." The new dosage form is emerging onto the U.S. market just as Merck is beginning to face generic competition for its oral indomethacin. Merck filed the NDA for the product in 1975. According to the company, the suppository form already accounts for approximately one third of Indocin sales worldwide, with percentages in major European markets ranging from 27% in Germany to a high of 76% in Spain. Suppositories now account for 30% of Canadian Indocin sales, the firm said. Like the capsule and sustained release form of the drug already available in the U.S., the Indocin suppository is indicated for the treatment of active stages of moderate to severe osteoarthritis and moderate to severe rheumatoid arthritis in patients not responding to an adequate trial of aspirin and rest. Similarly, it is indicated for moderate to severe ankylosing spondylitis, acute painful shoulder and acute gouty arthritis. In addition to the contraindication of Indocin for patients who have nasal polyps associated with angioedema or a bronchospastic reaction to aspirin or other NSAIDs, the suppository is contraindicated in patients with a history of proctitis or recent rectal bleeding.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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