Mylan Pharmaceuticals Inc. – FDA CRL

Mylan Pharmaceuticals Inc. received a Tentative Approval from the FDA for its New Drug Application (NDA 204311) for Abacavir and Lamivudine Tablets for Oral Suspension, 60 mg/30 mg, intended for HIV-1 infection treatment. This action, dated October 23, 2014, was granted under 21 CFR 314.105 and Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. This status is based on the application data and the acceptable status of current good manufacturing practices (CGMPs) at its facilities. The primary condition for the tentative status is the ongoing patent and exclusivity protection for the listed reference drug products. Final approval cannot be issued until these periods expire. To achieve final approval, Mylan must submit an amendment two to six months prior to patent expiration. This amendment requires updated labeling, including adherence to U.S. regulations such as unique drug product appearance (21 CFR 206) and child-resistant packaging (16 CFR 1700), along with current chemistry, manufacturing, controls data, and a safety update. Furthermore, Mylan must comply with post-market reporting requirements (21 CFR 314.80 and 314.81). If marketed in the U.S., the company must also address Pediatric Research Equity Act (PREA) obligations, join the antiretroviral pregnancy registry, and submit labeling under Structured Product Labeling guidelines. The FDA explicitly states that the drug product cannot be marketed in the United States without final agency approval, prohibiting its introduction into interstate commerce beforehand.