Mylan Symbicort Trial Looms As Company Eyes First US Generic
Teva Has Previously Settled ANDA Litigation
A trial will begin next month in Mylan’s bid to overcome patents shielding AstraZeneca’s Symbicort respiratory brand in the US. With rival Teva having previously settled ANDA action, Mylan is in the driving seat for a first substitutable generic.
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In October, the period during which Mylan may complete its merger with Upjohn will begin, while the FDA will begin holding monthly stakeholder meetings ahead of the third iteration of the Generic Drug User Fee Amendments program, also known as GDUFA III.
A revised draft guidance on metered-dose inhalers (MDIs) and dry powder inhalers (DPIs), offering recommendations on chemistry, manufacturing, and controls (CMC) information to be included in abbreviated new drug applications (ANDAs), as well as new drug applications (NDAs), has been published by the US Food and Drug Administration (FDA). The 46-page guidance document updates previous draft guidance from November 1998, reflecting current standards and requirements for development approaches for MDIs and DPIs, consistent with the FDA’s ‘quality by design’ (QbD) paradigm.
Mylan’s proposed $12bn combination with Pfizer’s Upjohn unit is expected to close next month following a settlement agreement with the FTC, with a requirement to address competition concerns in ten markets. The FTC was however strongly divided on the deal, with dissenters labelling the directives of the Commission as “deeply flawed, favoring routine over rigor.”