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FDA News Briefs for Friday, December 22, 2017

December 22, 2017

These Food and Drug Administration (FDA) developments came in this week:


FDA Approves New Drug for Low Blood Pressure in Septic Shock

The FDA has approved Giapreza (angiotensin II; La Jolla Pharmaceutical Company) to increase blood pressure in adults with septic or other distributive shock. Giapreza is an intravenous vasoconstrictor; the FDA recommends that the drug be administered through a central venous line. It will be commercially available in March 2018. More Information.


FDA Approves First Hydroxyurea Drug for Use in Children

The FDA has approved Siklos (hydroxyurea tablets; Addmedica) to reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients ≥ 2 years old with sickle cell anemia with recurrent moderate to severe painful crises. More Information.


Perjeta Now Indicated for Adjuvant Treatment of Early Breast Cancer

The FDA has granted a new indication for Perjeta (pertuzumab; Genentech). The intravenous HER2/neu receptor antagonist is now approved in combination with Herceptin (trastuzumab; Genentech) and chemotherapy for adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. More Information.


FDA Broadens Indication for Cabometyx

Cabometyx, (cabozantinib; Exelixis Inc.), an oral kinase inhibitor, is now indicated to treat advanced renal cell carcinoma (RCC). The FDA first approved Cabometyx in April 2016 to treat advanced RCC only in patients who have received prior anti-angiogenic therapy. The new label removes this requirement for prior therapy.  More Information.


Another Indication Approved for Opdivo

The FDA has approved Opdivo (nivolumab; Bristol-Myers Squibb) as an adjuvant treatment for patients with melanoma who have lymph node involvement or metastatic disease and who have undergone complete resection. The new indication includes both BRAF V600 mutation-positive and wild-type melanoma. More Information.


FDA Approves Steglatro, Steglujan, and Segluromet for Type 2 Diabetes

The FDA has approved Steglatro tablets (ertugliflozin; Merck and Pfizer) for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Steglatro is a sodium glucose co-transporter 2 inhibitor. The agency also approved Steglatro in fixed-dose combinations with metformin and sitagliptin, sold under the brand names Segluromet and Steglujan, respectively.   More Information.


FDA Expands Indications for Bosulif

Bosulif (bosutinib; Pfizer) is now indicated for first-line treatments of adult patients with chronic phase Philadelphia chromosome-positive, chronic myelogenous leukemia (Ph+ CML). This new indication is approved under accelerated approval based on molecular and cytogenetic response rates. Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow up trial. The FDA initially approved Bosulif for the treatment of adults with Ph+ CML who were resistant to or intolerant of prior therapy. More Information.


One Lot of Pantoprazole Sodium for Injection Recalled

The FDA announced on Wednesday that AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. More Information.   


FDA Removes Boxed Warning on Labels for Drugs Containing LABAs and ICS

The FDA has removed a boxed warning about asthma-related death from the drug labels of medicines that contain both inhaled corticosteroids (ICs) and long-acting beta agonists (LABAs). More Information.