Opinion ID: 688698
Heading Depth: 3
Heading Rank: 2

Heading: Ritodrine Hydrochloride

Text: 10 The FDA also approved Quad's application to market ritodrine hydrochloride (ritodrine), an injectable muscle relaxant. The ANDA for ritodrine submitted by Quad specified the addition of 1 mg/ml of sodium metabisulfate (bisulfate), an inert antioxidant. In its approval of the ANDA, the FDA allowed an overage of up to 1.05 mg/ml of bisulfate. Because the amount of bisulfate diminishes over time, the FDA also specified that ritodrine produced by Quad should contain no less than .7 mg/ml of bisulfate at the end of its shelf life. 11 Once the FDA has approved the manufacture and marketing of a generic drug according to a certain formula, a manufacturer is required to seek FDA approval before making any modification to that formula regardless of how insignificant the modification may be. See 21 C.F.R. Sec. 314.70 (1987). Soon after obtaining FDA approval for ritodrine, Chatterji directed that 1.075 mg/ml of bisulfate be used to ensure that the amount of bisulfate remaining at the end of the shelf life would comport with FDA requirements. Quad did not seek prior FDA approval for this formula change and falsely stated in a 1988 annual report to the FDA that no change in the formula for ritodrine had been made. It is not disputed that the minor formula change did not render Quad's ritodrine less effective or pose any danger to consumers who used the drug. Quad earned approximately $5.4 million in gross sales of ritodrine after the formula change.