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OptiNose Announces FDA Approval for ONZETRA™ Xsail™ (sumatriptan nasal powder), a New Treatment for Acute Migraine Using Bi-Directional™ Breath Powered® Technology

RouteOptiNose2016-02-01 16:11 Read   1115

OptiNose, a privately-held specialty biopharmaceutical company, today announced that its licensing partner, Avanir Pharmaceuticals, Inc. has reported that the U.S. Food & Drug Administration (FDA) approved ONZETRA™ Xsail™ (sumatriptan nasal powder), formerly AVP-825, for the acute treatment of migraine with or without aura in adults (see Full Prescribing Information and Limitations of Use at www.ONZETRA.com).

Avanir Pharmaceuticals Announces FDA Approval of ONZETRA™ Xsail™ (AVP-825) for the Acute Treatment of Migraine in Adults

RouteAvanir2016-02-01 15:48 Read   591

Avanir Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ONZETRA™ Xsail™ (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults.

Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE® (dalbavancin)

RouteAllergan2016-01-24 08:22 Read   195

Single-Dose Option Approved for Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

U.S. Food and Drug Administration Approves Humulin® R U-500 KwikPen

RouteEli Lilly2016-01-23 09:30 Read   187

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's (NYSE: LLY) Humulin®R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin.

Eagle Pharmaceuticals Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula

RouteEagle Pharmaceuticals2015-12-26 20:32 Read   355

Eagle Pharmaceuticals, Inc. announced today that FDA has approved Docetaxel Injection, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.