Paediatric Applications

A paediatric application approved for the new pharmaceutical form 7 years after approval of the original product. 

The generic manufacturer may not submit an ANDA for the new pharmaceutical form until 11.5 years after approval of the original product (i.e. 5 years from the date of approval of the new form + 0.5 years for the paediatric application). 

Bonnefont JP, Specola NB, Vassault A, Lombes A, Ogier H, de Klerk JB, Munnich A, Coude M, Paturneau-Jouas M, Saudubray JM (1990) The fasting test in paediatrics application to the diagnosis of pathological hypo- and hyperketotic states. Eur J Pediatr 150 80-85... 

Booker PD, Whyte SD. Paediatric applications of concentration-oriented anaesthesia. Best Pract Res Clin Anaesthesiol 2001 15 97-111. 

In the US, a manufacturer may not submit an application that relies on data from an approved submission for a period of 5 years after the reference product was authorised, unless the owner of the original data has granted a right of reference. The FDA may not approve an application that relies on data submitted as a supplement (e.g. new therapeutic indication) to an authorised drug for a period of 3 years after approval ofthe supplement. These exclusivity periods will be extended by 6 months if the reference submissions contain paediatric data. The FDA will also not... 

Serious or life-threatening diseases occurring in both adults and paediatric patients where there are currently no, or limited, therapeutic options -the paediatric component should be started early after initial proof of safety and of concept has been generated in adults, and the paediatric studies should form part of the marketing application. 

The types of trials to be undertaken demand a flexible approach, and depend on the seriousness of the disease, other therapeutic options and the pharmacokinetics at different ages. For example, if the disease process and efficacy endpoints are similar in adults and children, then an extrapolation from adult efficacy data, together with pharmacokinetic studies in the appropriate paediatric age range, together with safety studies, could form the basis of a successful application. Likewise, it may be possible to extrapolate efficacy from older to younger paediatric groups, with pharmacokinetic and safety studies in the relevant younger study subjects. Where there is no known correspondence between efficacy and... 

Such is the emphasis on the scientific development of medicines for paediatric use that Section 4 of the application for marketing authorisation specifically requires the applicant to state whether or not there is a paediatric development programme. Following the Council Resolution of December 2000, in February 2002 the EC published a consultation paper on Better Medicines for Children - proposed regulatory actions in... 

Applications are also encouraged for single-ingredient formulations suitable for use in paediatric populations, that support existing international and or national treatment guidelines for paediatric antiretroviral therapy (ART). 

SP27 pump Traditional pump design, compatible with wide range of nasal applicators for paediatric, adult or geriatric use. Airless/preservative-free systems also available. Acetal, polyethylene, polypropylene, elastomer, stainless steel (contact] Typical dose 50, 70, 100, 130 pL For 200 X 100 pL doses (example] volume = 102.8 pL 4.2°/o (distilled water]... 

The drug more or less shares the activities and applications of the parent compound i.e., sulfisoxazole. However, the drug is practically tasteless as compared to the parent drug hence, most suitable for liquid oral formulations for paediatric usage. 

If the existing data allowed adaptation of the paediatric use information, a supplemental new drug application was required to be submitted to the FDA for approval of a change in the PI. In this situation if there was insufficient information to support use of the drug in children, manufacturers were required to include a statement in the PI... 

Napp, J., Mathejczyk, J.E., Alves, F. Optical imaging in vivo with a focus on paediatric disease technical progress, current preclinical and clinical applications and future perspectives. Pediatric Radiology 41(2), 161-175 (2011)... 

Anatomical and biomechanical factors account for the difference in injury patterns encountered between children and adults. This chapter will discuss the basic concepts of ultrasound, the normal appearance of the musculoskeletal tissues and the applications of ultrasound in paediatric musculoskeletal trauma. 

Sam T, Ernest TB, Walsh J, Williams JL (2012) On behalf of the European paediatric formulation initiative (EuPFI). A benefit/risk approach towards selecting appropriate pharmaceutical dosage forms - an application for paediatric dosage form selection. Int J Pharm 435 115-123... 

Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use and specific rules for medicinal products for paediatric use, orphan, herbal medicinal products and advanced therapies (mentioned in Sect. 35.4.3)... 

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