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India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.
Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.
In this podcast discussion, Generics Bulletin editor David Wallace talks to Duncan Emerton, director of Custom Intelligence and Analytics for Informa Pharma Intelligence, about the UK's new licensing procedure for biosimilars.
Australia’s Therapeutic Goods Administration has set out proposals for a change to early-notification requirements for generic and biosimilar sponsors.
The AAM has published a position paper on nitrosamines that urges the FDA to revisit and reassess its safety limits for nitrosamines in pharmaceuticals, while also proposing a “science-driven” risk-based approach to evaluate drugs for the potential presence of nitrosamines.
Teva, Sun and the AAM are among those urging the CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program.
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