Zydus Cadila has claimed eligibility for periods of 180-day exclusivity linked to two of its recent US generic approvals, for rivals to Imbruvica and Opsumit.
Zydus Cadila has claimed eligibility for 180-day exclusivity periods linked to two generics that have just been approved by the US Food and Drug Administration.
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In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.
Generics Bulletin reviews global regulatory developments across the world.
Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.
As the Trump Administration continues to send ripples across industries, Tevogen has launched a new generic drugs-focused endeavor that plans to reshore production to the US.
