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May 17, 2013
FDA advisory committee to meet in July on opioid painkiller

A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

SYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

Australia-based QRxPharma said the FDA had determined that an advisory committee would meet on July 17 to consider a resubmitted application for Moxduo, an immediate-release formulation of the opioid painkillers morphine and oxycodone.

May 13, 2013
FDA ruling on opioid painkiller deals blow to Endo

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

May 2, 2013
National Alliance for Hispanic Health partners with Acetaminophen Awareness Coalition

The National Alliance for Hispanic Health on Thursday announced a partnership with the Acetaminophen Awareness Coalition to increase awareness among Spanish-speaking consumers for the importance of safe use of medicines that contain acetaminophen.

WASHINGTON — The National Alliance for Hispanic Health on Thursday announced a partnership with the Acetaminophen Awareness Coalition to increase awareness among Spanish-speaking consumers for the importance of safe use of medicines that contain acetaminophen. Many Hispanic consumers are not aware of any health risks associated with taking too much acetaminophen and do not check to see if their medicines contain acetaminophen, a drug ingredient in more than 600 over-the-counter and prescription medicines, according to Community Panel Discussions recently conducted by the Alliance.

May 1, 2013
Teva introduces generic bronchospasm drug

Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.

Teva announced the introduction of levalbuterol inhalation solution. The product is a generic version of Sunovion's Xopenex and is available in the 0.31 mg, 0.63 mg and 1.25 mg strengths.

Various versions of the drug had sales of $438.8 million in 2012, according to IMS Health.

April 30, 2013
Aurobindo receives FDA approval for hypertension, antibiotic drugs

The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

HYDERABAD — The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

The company announced Tuesday the approval of quinapril tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of Pfizer's Accupril and is used to treat high blood pressure. Various versions of the drug had sales of about $49 million during the 12-month period ending in September, according to IMS Health.

April 24, 2013
FDA approves drug for opioid-induced constipation

The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

BETHESDA, Md. — The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

April 16, 2013
FDA approves 200-mg strength of Warner Chilcott antibiotic

The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

DUBLIN — The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of the 200-mg strength of Doryx (doxycycline hyalite) delayed-release tablets, which the company plans to release in July 2013.

Doryx delayed-release tablets are already available in the 75-mg, 100-mg and 150-mg strengths.

 

April 8, 2013
Teva introduces generic painkiller

Teva Pharmaceutical Industries has launched a generic opioid medication for treating pain, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has launched a generic opioid medication for treating pain, the company said.

Teva announced the introduction of oxymorphone hydrochloride tablets.

The drug is a generic version of Endo Pharmaceuticals' Opana and will be available in the 5 mg and 10 mg strengths in bottles of 100 tablets.

 

March 26, 2013
FDA approves Actavis drug for opioid dependence

The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

 

March 18, 2013
FDA approves Mylan bronchospasm drug

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

PITTSBURGH — The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

March 14, 2013
FDA to review experimental opioid drug

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

March 5, 2013
Amneal ships opioid-dependence drug

Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

The generic drug maker announced the shipment of buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The Food and Drug Administration approved the drug in February.

The drug includes a risk evaluation and mitigation strategy, or REMS, a program required by the FDA to ensure that its benefits outweigh its risks.

February 25, 2013
FDA approves Amneal opioid-dependence drug

Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

 

February 14, 2013
Actavis can launch generic painkiller in May 2014 under settlement

Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

PARSIPPANY, N.J. — Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

The companies settled patent lawsuit regarding Actavis' generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32-mg strength. The companies settled litigation regarding the 8-mg, 12-mg and 16-mg strengths last month.

January 23, 2013
FDA approves Novartis drug for rare blood disorder

The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

The FDA announced the approval of Novartis' Exjade (deferasirox) for patients ages 10 years and older with chronic iron overload resulting from nontransfution-dependent thalassemia, or NTDT. A companion diagnostic, FerriScan, made by Australia-based Resonance Health, also was approved.

January 9, 2013
WEB FEATURE: FDA guidance aims to encourage abuse-deterrent painkillers

One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

SILVER SPRING, Md. — One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

January 3, 2013
Teva announces inhaler with dose counter for bronchospasm

An inhaler for patients with bronchospasm that includes a dose counter has become available from Teva Respiratory, the company said Thursday.

NORTH WALES, Pa. — An inhaler for patients with bronchospasm that includes a dose counter has become available from Teva Respiratory, the company said Thursday.

The company, which is the branded respiratory division of Israeli drug maker Teva Pharmaceutical Industries, announced the available of ProAir HFA (i.e., albuterol sulfate), for patients aged 4 and older to prevent and treat bronchospasm with reversible obstructive airway disease and prevent exercise-induced bronchospasm. The inhaler received Food and Drug Administration approval in March 2012.

December 21, 2012
Federal court rules against Endo in painkiller case

A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.

November 29, 2012
FDA approves Mylan overactive bladder drug

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.

Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.

October 5, 2012
AccuDial introduces five APAP products featuring readily comprehensive weight-based dosing instructions

AccuDial Pharmaceutical earlier this year introduced five SKUs across its Children’s AccuDial Acetaminophen Oral Suspension, featuring one of the only weight-based dosing acetaminophen products with an interactive, rotating label.

PALM BEACH GARDENS, Fla. — AccuDial Pharmaceutical earlier this year introduced five SKUs across its Children’s AccuDial Acetaminophen Oral Suspension, featuring one of the only weight-based dosing acetaminophen products with an interactive, rotating label. The single-ingredient products, indicated to help reduce fever in children, are timely for the coming cough-cold season. Children's AccuDial Acetaminophen Oral Suspension will retail for a suggested $4.99 and is available in five flavors: grape, dye-free cherry, cherry, bubble gum and strawberry. 

September 25, 2012
Watson recalls two lots of opioid painkiller

Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

The drug maker announced the recall of hydrocodone bitartrate and acetaminophen tablets in the 10 mg/500 mg strengths based on a customer complaint of tablets that were thicker and darker-colored than the others.

September 20, 2012
Dr. Reddy's launches antibiotic products

Drug maker Dr. Reddy's Labs has launched a generic antibiotic drug, the company said Thursday.

HYDERABAD, India — Drug maker Dr. Reddy's Labs has launched a generic antibiotic drug, the company said Thursday.

The India-based company announced the launch of amoxicillin tablets, capsules and oral suspension. The tablets are being launched in the 500-mg and 875-mg strengths, while the capsules are in the 250-mg and 500-mg strengths, and the oral suspension is in the 125-mg-, 200-mg-, 250-mg- and 400-mg-per-5-mL strengths.

September 7, 2012
Perrigo seeks approval for generic bronchospasm drug

Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

ALLEGAN, Mich. — Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

August 29, 2012
Nucynta ER approved as neuropathic pain treatment for DPN patients

The Food and Drug Administration has approved a supplemental new drug application for an opioid analgesic to treat diabetes-related pain.

RARITAN, N.J. — The Food and Drug Administration has approved a supplemental new drug application for an opioid analgesic to treat diabetes-related pain.

August 8, 2012
FDA approves morphine sulfate oral solution

The Food and Drug Administration has approved an oral painkiller made by Perrigo, the drug maker said Wednesday.

ALLEGAN, Mich. — The Food and Drug Administration has approved an oral painkiller made by Perrigo, the drug maker said Wednesday.

Perrigo announced the approval of morphine sulfate oral solution in the 100-mL/5% strength. The drug is a Schedule II controlled substance and is used to treat moderate to severe acute and chronic pain. Sales of the drug are about $26 million per year, according to Wolters Kluwer Health. Perrigo said it would ship the drug immediately.