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FDA Watch: Approvals for AbbVie, Adherium; designations for Allergan, Assembly

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FDA Watch: Approvals for AbbVie, Adherium; designations for Allergan, Assembly

Approvals and designations made by the U.S. Food and Drug Administration for the week ended July 27.

Approvals

* AbbVie Inc. and Neurocrine Biosciences Inc.'s Orilissa, to treat pain associated with endometriosis. The FDA previously granted Orilissa, a potential blockbuster drug, priority review status.

* Adherium Ltd.'s Hailie sensor for asthma inhalers. The Hailie online platform can now be used with Teva Pharmaceutical Industries Ltd.'s ProAir inhaler as well as GlaxoSmithKline PLC's Ventolin and Flovent inhalers. Hailie is already approved for use with AstraZeneca PLC's Symbicort inhaler.

* Endomagnetics Ltd.'s Sentimag System, to detect whether breast cancer has spread to other parts of the body.

FDA headquarters in Silver Spring, Md.
Source: Associated Press

Complete response letters

* Insys Therapeutics Inc.'s buprenorphine spray, meant for moderate-to-severe acute pain. The FDA flagged potential safety concerns for the drug.

Fast track

* Allergan PLC's AGN-241751, for patients with major depressive disorder.

* Assembly Biosciences Inc.'s ABI-H0731, for patients with chronic hepatitis B infection.

* Apellis Pharmaceuticals Inc.'s APL-2, for patients with geographic atrophy.

* BeiGene Ltd.'s zanubrutinib, for patients with Waldenström macroglobulinemia, a form of non-Hodgkin lymphoma.