context: Therefore, the FDA properly applied its regulations and Barr when it concluded that Mylan's approval with a delayed effective date was a "tentative approval." Furthermore, there are clear public health and safety issues in play that require the FDA to give final effective approval before a generic drug can be introduced into the market.
citation_a.signal: see also
citation_a.identifier: 307 F.Supp.2d 19, 19
citation_a.parenthetical: adopting the FDA's argument that "[approvals do not become effective by operation of law because the FDA has an ongoing health and safety responsibility to perform, and an applicant has no vested right to enter the market until the FDA gives its final formal approval"
citation_a.sentence: Barr, 238 F.Supp.2d at 246 (“Significant events occurring prior to the effective date can, and often must, delay the effective date of ANDA approvals.”); see also Ranbaxy, 307 F.Supp.2d at 19 (adopting the FDA’s argument that “[approvals do not become effective by operation of law because the FDA has an ongoing health and safety responsibility to perform, and an applicant has no vested right to enter the market until the FDA gives its final formal approval”).
citation_b.signal: no signal
citation_b.identifier: 238 F.Supp.2d 246, 246
citation_b.parenthetical: "Significant events occurring prior to the effective date can, and often must, delay the effective date of ANDA approvals."
citation_b.sentence: Barr, 238 F.Supp.2d at 246 (“Significant events occurring prior to the effective date can, and often must, delay the effective date of ANDA approvals.”); see also Ranbaxy, 307 F.Supp.2d at 19 (adopting the FDA’s argument that “[approvals do not become effective by operation of law because the FDA has an ongoing health and safety responsibility to perform, and an applicant has no vested right to enter the market until the FDA gives its final formal approval”).