Date:01/04/2005 URL: http://www.thehindubusinessline.com/2005/04/01/stories/2005040101910200.htm

Back J&J sends interim response to FDA

Our Bureau

Mumbai , March 31

JOHNSON & Johnson (J&J) has sent an interim response to the Maharashtra Food and Drug Administration (FDA) seeking more time to respond to the regulatory authority's concerns on J&J's oil for infants.

This comes even as the FDA's 15-day deadline to respond to the show-cause notice sent by it expired on March 31.

The FDA has given the multinational company 15 more days to respond to the show-cause notice, an official familiar with the J&J related developments told Business Line. The regulatory authority had also visited the company's facility in Mulund, in Mumbai's suburb, the official said.

Earlier this month, the FDA had issued a show-cause notice to J&J asking the company to drop "baby" from its label. The regulatory authority had expressed concern over whether the mineral oil used in the product was unfit for babies.

Following this development, Chinese authorities too had put J&J's baby oil under the scanner. After investigations, however, they cleared the products in question, stating that they met the requirements, news reports said. Meanwhile, the FDA has also sent a similar notice to Wipro on its baby oil.