FDA’s ANDA Approvals
Generic drug approvals and tentative approvals for late January.
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Strides has set a sales target of $200-400m for Stelis’s generic injectables business in two to four years as part of its plan to reach $800m in total revenues in four years. Meanwhile, Stelis’s Rh-teriparatide for osteoporosis and sodium hyaluronate for osteoarthritis await Phase III incremental studies in the US.
US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca choose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.