FDA Approves Zutripro
FDA Approves Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution
MADISON, Miss.--(BUSINESS WIRE)--Jun 13, 2011 - Cypress Pharmaceutical announced today that the Food and Drug Administration (FDA) approved a new drug application (NDA) for Zutripro(hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution (CIII). The FDA also approved Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution (CIII). Both products are indicated for the relief of cough and symptoms associated with the common cold.
Zutripro and Rezira Oral Solutions are the only FDA approved hydrocodone cough and cold combinations containing a nasal decongestant1. The approval of Zutripro and Rezira Oral Solutions marks the first NDA approval by the FDA for a liquid hydrocodone cough medication since 19901.
These products will be marketed by Hawthorn Pharmaceuticals, a subsidiary of Cypress Pharmaceutical, Inc.
"Currently, there are very few prescription products for patients suffering from cough and the symptoms associated with the common cold," said Chris Smith, EVP of Sales for Hawthorn Pharmaceuticals. "With Zutripro and Rezira Oral Solutions, healthcare practitioners finally have more options when treating patients suffering from a cough and symptoms associated with the common cold. Additionally, Zutripro and Rezira both contain a decongestant which is very beneficial considering the fact that one of the most common symptoms of the common cold is nasal congestion.2"
Zutripro and Rezira Oral Solutions are available through all national drug wholesalers, as well as chain drug stores and other distribution channels and will begin shipping immediately. Zutripro and Rezira Oral Solutions are available by prescription only in the United States.
About Zutripro
Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride) Oral Solution (CIII) is indicated for the relief of cough and nasal congestion associated with common cold and relief of upper respiratory allergy symptoms including nasal congestion in adults 18 years of age and older.
Important Safety Information
Zutripro Oral Solution is contraindicated in individuals with hypersensitivity to hydrocodone, pseudoephedrine HCl, chlorpheniramine, or any of the inactive ingredients; individuals receiving monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping such therapy; and individuals with narrow angle glaucoma, urinary retention, severe hypertension or severe coronary artery disease. The possibility of tolerance and/or dependence, particularly in patients with a history of drug dependence, should be considered. Avoid in patients with head injury, intra-cranial lesions, or increased intracranial pressure. Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Zutripro Oral Solution may produce marked drowsiness. Zutripro Oral Solution should not be taken with alcohol or other CNS depressants. Use with caution in patients with acute abdominal conditions and in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy, urethral stricture, or asthma.
The most common adverse reactions of Zutripro Oral Solution are CNS and cardiovascular reactions including the following: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, or sleeplessness; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, restlessness, insomnia, irritability, or tremor.
About Cypress Pharmaceutical, Inc.
Cypress Pharmaceutical, Inc., founded in 1993, is a specialty pharmaceutical company that develops, markets and distributes generic prescription pharmaceutical products to leading national pharmaceutical wholesalers, chain drug stores, distributors, and other retail merchandisers.
About Hawthorn Pharmaceuticals, Inc.
Hawthorn Pharmaceuticals, Inc, founded in 1998, is a commercial stage specialty pharmaceutical company that develops and markets prescription pharmaceutical products to multiple physician specialties. Hawthorn's broad pipeline represents the therapeutic areas of respiratory, nephrology, dermatology, oncology, CNS and neurology. The company has established strategic corporate alliances with multinational companies. For more information, please visit the Hawthorn Pharmaceuticals web site at www.hawthornrx.com.
For Full Prescribing Information on Zutripro Oral Solution click here.
References:
1. Drugs@FDA search. 9 June 2011.
2. Allen G, Kelsberg G, Jankowski T. Do nasal decongestants relieve symptoms? Journal of Family Practice 2003; 52; No. 9.
Contact: Cypress Pharmaceutical, Inc.1. Drugs@FDA search. 9 June 2011.
2. Allen G, Kelsberg G, Jankowski T. Do nasal decongestants relieve symptoms? Journal of Family Practice 2003; 52; No. 9.
Max Draughn, Chief Executive Officer, 800-856-4393
mdraughn@cypressrx.com
mdraughn@cypressrx.com
Posted: June 2011
FDA Approves Oxecta
Pfizer and Acura Announce FDA Approval of Oxecta (Oxycodone HCl, USP) CII
NEW YORK--(BUSINESS WIRE)--Jun 20, 2011 - Pfizer Inc. and Acura Pharmaceuticals Inc. announce the marketing approval from the U.S. Food and Drug Administration (FDA) of Oxecta(oxycodone HCl, USP) Tablets CII. Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.
Oxecta is the first immediate-release oxycodone HCl medicine that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse. This AVERSION Technology is a unique composition of commonly used pharmaceutical ingredients. Pfizer is licensing the technology in Oxecta fromAcura.
Opioid medications are an important treatment option for patients with moderate to severe pain who are not adequately managed by other pain treatments. However, abuse and misuse of opioids is a serious public health issue that is the focus of a number of recent United States government initiatives.
"We recognize our responsibility to physicians and patients and remain committed to appropriate access to pain treatment and developing medicines to potentially address this important public health and safety issue," said Olivier Brandicourt, Pfizer president and general manager, Primary Care. "Oxecta will further expand Pfizer's presence in pain management and complements our growing, robust portfolio of treatments and medicines in development for pain relief, one of our strategic, high-priority disease areas. We are pleased to bring Oxecta to patients and physicians with our partner Acura."
"We are excited to be partnered with Pfizer to bring Oxecta to patients who need opioids to manage their pain," said Robert Jones, interim president and chief executive officer of Acura Pharmaceuticals, Inc. "Acura is focused on developing technologies that are intended to potentially deter abuse and misuse."
Important Safety Information
Oxecta is contraindicated in patients with respiratory depression in unmonitored settings and in the absence of resuscitative equipment, in any patient who has or is suspected of having paralytic ileus, in patients with acute or severe bronchial asthma or hypercarbia, and in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product.
Respiratory depression is the primary risk of Oxecta. This is more common in elderly or debilitated patients, in those suffering from conditions such as COPD, severe asthma, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients.
Oxecta contains oxycodone HCl, an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addictions. Oxecta can be abused in a manner similar to other opioids and narcotics. This should be considered when prescribing or dispensing oxycodone HCl in situations where the physician or pharmacist is concerned about an increased risk of misuse or abuse. Oxecta may be abused by crushing, chewing, snorting or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death. Oxecta should not be given to anyone other than the individual for whom it was prescribed. Keep Oxecta in a locked cabinet, drawer or medicine safe so that it will not be stolen.
There is no evidence that Oxecta has a reduced abuse liability compared to immediate-release oxycodone.
Take each Oxecta tablet with enough water to ensure complete swallowing immediately after placing in the mouth, and Oxecta must be swallowed whole. As Oxecta is not amenable to crushing and dissolution, do not use Oxecta in nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.
Patients who have not been receiving opioid analgesics should start on Oxecta in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient's response to their first dose of Oxecta. Patients with chronic pain may need to be dosed at the lowest dosage level that will achieve acceptable pain relief and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis. When a patient no longer needs treatment with Oxecta after long-term use, it is important to gradually taper Oxecta over time to prevent withdrawal symptoms.
Patients taking Oxecta in combination with other medicines like sedatives, anesthetics or narcotics may have serious problems such as respiratory depression, low blood pressure, profound sedation, or coma. Do not drink alcoholic beverages or take any medicines containing alcohol while taking Oxecta.
Use Oxecta with caution in patients with head injuries or other conditions that increase pressure in the brain, shock with low blood volume, severe undiagnosed abdominal conditions, history of seizures, severe kidney or liver disease, gall bladder disease, Addison's disease, hypothyroidism, enlarged prostate or other illnesses that make urination difficult and elderly or debilitated patients. Do not use Oxecta in patients with intestinal obstruction especially paralytic ileus.
Patients taking Oxecta should use caution when driving a car, operating heavy machinery or doing similar, potentially dangerous tasks as Oxecta may impair abilities needed to drive or perform potentially dangerous activities.
The most common adverse reactions are nausea, constipation, vomiting, headache, itchiness, trouble sleeping, dizziness, loss of strength/energy, and sleepiness.
Keep Oxecta out of the reach of children. If a child accidently takes Oxecta, seek emergency medical help immediately.
For additional information on the prescribing information for Oxecta, please call 1 (800) 776-3637.
Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication
January 13, 2011
ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.
BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.
RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.
Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products.
http://www.drugs.com/fda/acetaminophen-products-limited-325-mg-per-unit-safety-communication-12886.html#Anakinra for rheumatoid arthritis: A modest benefit with some risk
New research supports a modest beneficial effect of anakinra for rheumatoid arthritis patients, but warns against potential risks for serious infections and its use with other biologic medications.
Rhodiola Rosea Improves Work Quality and Reduces Depression and Fatique
(NaturalNews) Nearly one in five Americans will suffer from depression (along with related symptoms such as fatigue) at some time in their life. For people between 14 and 44, depression is the leading cause of medical disability. Depressed people are more than twice as likely as others to take sick days, and when they do make it to work they suffer from lost productivity due to a reduced ability to concentrate and to organize their day. Drugs, the usual medical intervention for depression, are expensive and come with unpleasant side effects such as sexual dysfunction, dry mouth, or drowsiness. Fortunately there areherbalremedies with minimal if any side effects which effectively relievedepressionsymptoms. One of the best is Rhodiola Rosea, an herb from the Crassulaceae family which grows in cold areas of the world such asRussia, Scandinavia, Iceland and the Arctic.
Learn more:http://www.naturalnews.com/030784_Rhodiola_Rosea_fatigue.html#ixzz18eIsMQLz
FDA: Avastin should not be used for breast cancer (Update)
(AP) -- Federal health authorities are recommending the blockbuster drug Avastin no longer be used to treat breast cancer, saying recent studies failed to show the drug's original promise to help slow the disease.
