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Infants' Advil

This article was originally published in The Tan Sheet

Executive Summary

Whitehall-Robins' NDA 21-812/SE5-003 for ibuprofen oral suspension concentrated drops (50 mg/1.25 mL) is approved Jan. 12. The product is indicated for use in children ages 6-23 months. Whitehall currently markets a number of Children's Advil products in drop, suspension and tablet formulations. Infants' Advil will compete with McNeil Consumer Healthcare's Infants' Tylenol pain reliever and fever reducer products

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Infants' Advil

Expanded dosing of Whitehall-Robins' Pediatric Advil Drops, to be launched this year as Infants' Advil Concentrated Drops, will come in fruit flavor in .5 fl. oz. (15 mL) and .25 fl. oz. (7.5 mL) sizes. The alcohol-free product (ibuprofen oral suspension 50 mg/1.25 mL) is for ages 6-23 months; Pediatric Advil Drops are for 2-3 year-olds. Labeling for the new drops will provide a dosing chart specifying a 1.25 mL dose should be given to infants weighing 12 lb.-17 lb. or ages 6-11 months, and a 1.875 mL dose should be provided for those 18 lb.-23 lb. or 12-23 months. For those under six months, a doctor should be consulted before use, the label states. Whitehall filed the supplemental NDA for the product June 15, 1998. FDA approved it Jan. 12 (1"The Tan Sheet" Jan. 17, In Brief)

Infants' Advil

Expanded dosing of Whitehall-Robins' Pediatric Advil Drops, to be launched this year as Infants' Advil Concentrated Drops, will come in fruit flavor in .5 fl. oz. (15 mL) and .25 fl. oz. (7.5 mL) sizes. The alcohol-free product (ibuprofen oral suspension 50 mg/1.25 mL) is for ages 6-23 months; Pediatric Advil Drops are for 2-3 year-olds. Labeling for the new drops will provide a dosing chart specifying a 1.25 mL dose should be given to infants weighing 12 lb.-17 lb. or ages 6-11 months, and a 1.875 mL dose should be provided for those 18 lb.-23 lb. or 12-23 months. For those under six months, a doctor should be consulted before use, the label states. Whitehall filed the supplemental NDA for the product June 15, 1998. FDA approved it Jan. 12 (1"The Tan Sheet" Jan. 17, In Brief)

Infants' Advil

Expanded dosing of Whitehall-Robins' Pediatric Advil Drops, to be launched this year as Infants' Advil Concentrated Drops, will come in fruit flavor in .5 fl. oz. (15 mL) and .25 fl. oz. (7.5 mL) sizes. The alcohol-free product (ibuprofen oral suspension 50 mg/1.25 mL) is for ages 6-23 months; Pediatric Advil Drops are for 2-3 year-olds. Labeling for the new drops will provide a dosing chart specifying a 1.25 mL dose should be given to infants weighing 12 lb.-17 lb. or ages 6-11 months, and a 1.875 mL dose should be provided for those 18 lb.-23 lb. or 12-23 months. For those under six months, a doctor should be consulted before use, the label states. Whitehall filed the supplemental NDA for the product June 15, 1998. FDA approved it Jan. 12 (1"The Tan Sheet" Jan. 17, In Brief)

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