FDA drug approvals-May 2015


FDA actions in brief, complete response, breakthrough therapy designation, fast-track designations, orphan drug designations

FDA actions in brief

Sirolimus (Rapamune, Wyeth Pharmaceuticals) was approved to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age. This is the first drug approved to treat the disease.

Eluxadoline (Viberzi, Patheon Pharmaceuticals, distributed by Forest Laboratories) twice-daily, oral treatment was approved for adults with irritable bowel syndrome with diarrhea (IBS-D). Eluxadoline has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.

Rifaximin (XifaxanSalix Pharmaceuticals) was approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. 

Insulin lispro 200 units/mL; U-200 (Humalog 200 units/mL KwikPenEli Lilly and Company), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog (insulin lispro 100 units/mL) was approved to improve glycemic control in people with type 1 and type 2 diabetes. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog.

A label update for collagenase clostridium histolyticum or CCH (Xiaflex, Endo) was approved for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord. The updated label now includes a long-term, observational study demonstrating the rate of recurrence for up to 5 years after successful treatment with Xiaflex, and the efficacy and safety of retreatment in patients with recurrent DC.

Tiotropium bromide and olodaterol (Stioloto Respimat, Boehringer Ingelheim) Inhalation Spray was approved as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Stioloto Respimat is not indicated to treat asthma or acute deterioration of COPD.

A supplemental drug application was approved for Baxter International Inc. to establish its Sabinanigo, Spain, facility as an approved manufacturing site for 0.9% Sodium Chloride Injection, USP, for the US market. These solutions have a wide range of applications which include regulation of blood pressure, hydration, electrolyte balance, medication and nutrition delivery, flushing, clearing out IV lines and feed tubes, wound cleaning, renal dialysis and in plasma collection. The approval includes product presentations in 250 mL, 500 mL and 1,000 mL, which Baxter has been distributing in the United States to alleviate a drug shortage with the knowledge of FDA. 

Sumatriptan and naproxen sodium (TreximetPernix Therapeutics) was approved for the treatment of migraines in pediatric patients.

Moxifloxacin (Avelox, Bayer HelathCare) was approved to treat patients with plague, a rare and potentially fatal bacterial infection.

Fentanyl iontophoretic transdermal system (IonsysThe Medicines Company) was approved for the short-term management of acute postoperative pain in hospitalized adults needing opioid analgesia.

Fluticasone furoate/vilanterol (Breo ElliptaTheravance, Inc.) for the treatment of asthma in adults.

Codeine polistirex and chlorpheniramine polistirex (Tuzistra XR,Vernalis plc and Tris Pharma) extended-release oral suspension, CIII (DEA Schedule III) for cough and cold treatment.

Fibrin sealant [human] (RaplixaProFibrix BV, a wholly owned subsidiary of The Medicines Company) was approved to help control bleeding during surgery.

Complete response

AMAG Pharmaceuticals' manufacturing supplement seeking approval for a single-dose vial of hydroxyprogesterone caproate injection (Makena). In the complete response letter, FDA requested additional information related to manufacturing procedures for the single-dose vial at a new third-party manufacturer. The company remains committed to commercializing a single-dose vial of Makena and plans to work with FDA on a timely response.

Paliperidone palmitate (Invega Sustenna, Janssen Pharmaceuticals) regarding the supplemental new drug application (sNDA) to include data showing that treatment is effective 6 months longer than commonly prescribed oral antipsychotics in people with schizophrenia. Janssen is evaluating the content of the complete response letter.

Breakthrough therapy designation

Venetoclax (AbbVie, in partnership with Genentech and Roche), an inhibitor of the B-cell lymphoma-2 (BCL-2) protein for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.


NEXT: Fast-track designation


Fast-track designation

Abuse-deterrent Oxycodone HCl (Rexista Oxycodone XR, Intellipharmaceutics International) extended-release tablets development program.

Human Retinal Progenitor Cell (hRPC) therapy candidate (ReNeuron) for retinitis pigmentosa (RP). RP is a group of hereditary diseases of the eye that lead to progressive loss of sight due to cells in the retina becoming damaged and eventually dying.

Luspatercept (Celgene and Acceleron) for 2 separate indications; the use of luspatercept for the treatment of patients with transfusion dependent beta-thalassemia and the use of luspatercept for the treatment of patients with non-transfusion dependent beta-thalassemia.

AG-120 (Agios Pharma) for the treatment of patients with acute myelogenous leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation.

Sacituzumab govitecan (IMMU-132, Immunomedics) for the treatment of patients with metastatic non–small cell lung cancer.

Evofosfamide (previously known as TH-302) (Merck KGaA and Threshold), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer.

CD101 IV (Cidara Therapeutics) Qualified Infectious Disease Product (QIDP) for treatment of candidemia and invasive candidiasis.

Cobiprostone (Sucampo Pharmaceuticals), a locally acting chloride channel activator, for the prevention of oral mucositis. 

Orphan drug designation

ABX-101 and ABX-102 for Sanfilippo Syndromes (MPS IIIA and MPS IIIB) (PlasmaTech Biopharmaceuticals) was also granted rare pediatric disease designation.

Pelareorep (Reolysin, Oncolytics Biotech) for pancreatic, peritoneal, ovarian, and fallopian tube cancers, in addition to the treatment of malignant gliomas in April.

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