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FDA Watch: Approvals for Merck & Co., AbbVie; designations for Insys, MeiraGTx

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Aug. 31.


* Merck & Co. Inc.'s Delstrigo and Pifeltro, for HIV-1 infection in adults who have not previously received antiretroviral treatment.

* AbbVie Inc.'s Imbruvica, combined with Roche Holding AG's Rituxan, for adults with Waldenström's macroglobulinemia. Imbruvica is already approved as a single treatment for the blood cancer subtype.

* Aquestive Therapeutics Inc.'s Sympazan, an oral film version of epilepsy drug clobazam, which H. Lundbeck A/S markets as Onfi. Sympazan will receive final approval in October, following the expiration of Onfi's orphan drug exclusivity.

* Bayer AG's Jivi, to prevent bleeding in previously treated hemophilia A patients 12 years or older. The FDA also approved Jivi as an on-demand treatment and as a treatment after surgery to manage bleeding in the same patient population.

* Tetraphase Pharmaceuticals Inc.'s Xerava, for adults with complicated intra-abdominal infections.

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

Complete response letters

* Sunovion Pharmaceuticals Inc.'s dasotraline, for attention deficit hyperactivity disorder. The FDA requested additional clinical data on dasotraline's safety and efficacy.

* Ionis Pharmaceuticals Inc. and Akcea Therapeutics Inc.'s Waylivra, for familial chylomicronemia syndrome.

Fast track

* Insys Therapeutics Inc.'s epinephrine nasal spray, for anaphylaxis. Insys said the treatment can be a needle-free alternative to Mylan NV's EpiPen products.

Other designations

* Rare pediatric disease, for MeiraGTx Holdings plc's AAV-CNGA3, to treat achromatopsia.