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Linaclotide, (sold under the brand name Linzess in the US and Mexico, and as Constella elsewhere) [6] is a drug used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause.
Plecanatide, sold under the brand name Trulance, is a medication for the treatment of chronic idiopathic constipation (CIC) [4] and irritable bowel syndrome with constipation. [5] It is available in India under the brand name Plectide (OQM Div, MSN Laboratories, India).
Although there are a few exceptions, generally a bioequivalent comparison of Test to Reference formulations also requires administration after an appropriate meal at a specified time before taking the drug, a so-called "fed" or "food-effect" study. A food-effect study requires the same statistical evaluation as the fasting study, described ...
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...
The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. [2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name ...
This list contains 1200 recommendations for 591 drugs and 103 therapeutic equivalents. [20] A separate list for children up to 12 years of age, known as the WHO Model List of Essential Medicines for Children (EMLc), was created in 2007 and is in its 9th edition.
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