Montelukast is the leukotriene receptor antagonist. It works by blocking the action of leukotriene D4 in the lungs resulting in decreased inflammation and relaxation of smooth muscle. It is used for a number of conditions including asthma, exercise induced bronchospasm, allergic rhinitis, and urticaria. It is mainly used as a …
What is a DSUR? The development safety update report (DSUR) is pre-marketing periodic report which covers safety information of drugs, biological, vaccines and combo products under development (including marketed drugs that are under further study) among the ICH regions. DSUR for single active moiety and combined products: A single DSUR …
New Drug Application (NDA): The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a …
We need to be very careful when giving any medicine to an infant or a child. Even over-the-counter (OTC) medicines are serious medicines. Children cannot be considered as miniature adults and adult medications should never be used in children as children’s responds to drugs differently than adults. Only paediatric medications …
The clinical study report (CSR) is a crucial document in the drug development and regulatory submission process. According to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline E3, a CSR is an integrated report of a study of any therapeutic, prophylactic …
Investigational New Drug (IND): Once the preclinical stages including the required short term animal studies have been completed, the drug is ready to be moved into human testing. Before this can happen permission for human research must be obtained by submitting an Investigational New Drug (IND) application to the Food …
Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide. The aggregate safety reports are presented to regulators as soon as the medicine is marketed anywhere in the world and enables understanding …
Proton Pump Inhibitors (PPIs) — such as Prilosec, Protonix and Nexium, have long been one of the most prescribed medications to aid in the reduction of stomach acid. The use of these medicines among children is on the rise and so are potential side effects, which is sparking concern according …
Migraine headache pain is often described as an intense throbbing or pulsing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of individuals who suffer from migraine also experience aura shortly before the migraine. An aura can appear …
The U.S. Food and Drug Administration is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos. Consumers who have Johnson’s Baby Powder lot #22318RB …