Article Link: Arbor Pharmaceuticals Announces FDA Approval of Cetylev
Atlanta, GA, February 9, 2016 — Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Cetylev (acetylcysteine effervescent tablets for oral solution).
Cetylev is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. Acetaminophen overdose is the most common poisoning reported to emergency rooms in the United States. According to the American Association of Poison Control Centers there were 73,347 reported acetaminophen exposures in 2014 which resulted in 108 deaths.
Cetylev will be available in ready to use effervescent tablets intended to be mixed with water, resulting in a pleasant lemon-mint tasting solution. Currently, acetylcysteine solution is available in vials intended for inhalation which pharmacists typically mix with a diet cola for ingestion orally. It is also available in an intravenous dosage form which requires that patients be admitted into the hospital.
“For patients with acetaminophen overdose, it is critically important to administer acetylcysteine as quickly as possible to reverse or reduce potential fatal damage to the liver. Emergency rooms, ambulances and pharmacies will have a ready to use dosage form of acetylcysteine that can be administered quickly,” said Ed Schutter, President and CEO of Arbor. “Cetylev adds to our growing portfolio of now nineteen different approved prescription products that may help to improve the lives of our patients.”
Arbor plans to commence commercial manufacturing of Cetylev immediately and expects to have product available soon. The company will be promoting Cetylev through its team of 30 Hospital Account Specialists.
Cetylev is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).
Important Safety Information
- Hypersensitivity reactions, including generalized urticaria have been observed in patients receiving oral acetylcysteine for acetaminophen overdose. If hypersensitivity reactions occur, Cetylev should be discontinued unless it is deemed essential for patient management and the reactions can be otherwise controlled.
- Risk of upper gastrointestinal hemorrhage may increase due to occasional severe and persistent vomiting as a symptom of acute acetaminophen overdose. Treatment with Cetylev may aggravate the vomiting and increase the risk of upper gastrointestinal hemorrhage in at risk patients (e.g., those with esophageal varices, peptic ulcers, etc.). Consider the risk/benefit for patients at risk of hemorrhage versus the risk of developing hepatic toxicity, and treat with Cetylev as needed.
- Cetylev tablets contain sodium. Consider the total sodium content from dietary and non-dietary sources in patients who may be sensitive to excess sodium intake, such as those with congestive heart failure, hypertension, or renal impairment.
- Acetaminophen and acetylcysteine cross the placenta. Delaying treatment in pregnant women with acetaminophen overdose and potentially toxic acetaminophen plasma levels may increase the risk of maternal and fetal morbidity and mortality.
- There is no information regarding the presence of acetylcysteine in human milk, or the effects of acetylcysteine on the breastfed infant or on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cetylev and any potential adverse effects on the breastfed infant from Cetylev or from the underlying maternal condition.
- Please refer to Cetylev Prescribing Information for Recommended Dosage and Preparation and Administration Instructions in Adults and Pediatrics for Acute Acetaminophen Ingestion. For assistance with specific Cetylev dosage and administration information for acute ingestion or specific Cetylev dosage and administration information in patients with RSI, consider contacting your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.
The most common adverse reactions were nausea, vomiting, other gastrointestinal symptoms, and rash with or without fever.
Please click here for the full Prescribing Information for Cetylev or call 1-866-516-4950.
About Arbor Pharmaceuticals
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital and pediatric markets. The company has over 500 employees including 400 sales professionals promoting its products to physicians, hospitals, and pharmacists. Arbor currently markets 19 NDA and ANDA approved products with over 40 more in development. For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to email@example.com.
Source: Arbor Pharmaceuticals, LLC
Posted: February 2016
Cetylev (acetylcysteine) FDA Approval History
Source: FDA New Drug Approvals