New Formulations Archives

FDA Approves Genentech’s Xolair Prefilled Syringe Formulation

Allergic Asthma, Blockbusters, Chronic Idiopathic Urticaria, FDA/Regulatory, New Formulations, Syringes

The FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for Genentech’s Xolair as an additional formulation for allergic asthma and chronic idiopathic urticaria.

FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis

Approvals, FDA/Regulatory, Interleukin-6 (IL-6), New Formulations, Systemic Juvenile Idiopathic Arthritis (SJIA)

Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

Teva Announces FDA Approval of QVAR RediHaler Inhalation Aerosol

Approvals, Asthma, New Formulations

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration approved QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy in patients 4 years of age and older.