“Old” Antibiotics May Get Exclusivity Under New Law; 10 Drugs Could Benefit
Drug manufacturers could get marketing exclusivity for a handful of old antibiotics under legislation passed by the House and Senate last month
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FDA’s decision that vancomycin oral capsules do not qualify for Hatch-Waxman marketing protection under a 2008 law could become the focus of a legislative “fix” in pending user fee bills if lawmakers disagree with the agency’s conclusion that only approval of a “significant new use” for older antibiotics warrants exclusivity.
FDA delivers an 87-page chef d'oeuvre that concludes the ViroPharma’s long-running battle to block ANDA approvals. In the citizen petition response, FDA rejects the firm’s scientific and legal arguments and concludes the antibiotic is not eligible for three years of Hatch-Waxman marketing exclusivity under a 2008 law. Although ViroPharma says it plans to sue FDA, the company may have bigger problems on its hands with an FTC investigation.
Teva's brief at-risk launch of the acne product Solodyn followed by a settlement with Medicis may serve as template.