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May 17, 2013

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

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 9, 2013

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

May 1, 2013

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 26, 2013

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 24, 2013

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

Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

NEW YORK — Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

April 16, 2013

The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.

April 8, 2013

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.

 

April 4, 2013

The March/April 2013 Allergy Relief Ingredient Guide breaks down the indication, ingredients, purpose and dosage of Claritin-D, Allegra-D, Zyrtec-D, Benadryl-D, Advil Allergy and Congestion Relief, UrgentRx Allergy Attack, Hyland's Seasonal Allergy Relief, Similasan's Nasal Allergy Relief and Boiron's Sabadil.

The March/April 2013 Allergy Relief Ingredient Guide breaks down the indication, ingredients, purpose and dosage of Claritin-D, Allegra-D, Zyrtec-D, Benadryl-D, Advil Allergy and Congestion Relief, UrgentRx Allergy Attack, Hyland's Seasonal Allergy Relief, Similasan's Nasal Allergy Relief and Boiron's Sabadil.

March 26, 2013

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

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

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 12, 2013

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

March 5, 2013

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.

March 5, 2013

Ranbaxy Labs will market a drug for depression under an agreement with another company, the drug maker said Tuesday.

PRINCETON, N.J. — Ranbaxy Labs will market a drug for depression under an agreement with another company, the drug maker said Tuesday.

Ranbaxy said it had entered an in-licensing agreement with Alembic Pharmaceuticals to market desvenlafaxine base extended-release tablets. Alembic is the sponsor of a new drug application filed with the Food and Drug Administration for the drug, which is bioequivalent to Pfizer's Pristiq. Pristiq had sales of $590 million during the 12-month period that ended in January.

February 25, 2013

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.

 

January 25, 2013

Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area.

WHITEHOUSE STATION, N.J. — Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area. Most notable about this switch is the fact that the FDA approved Oxytrol for Women against the majority opinion of its Nonprescription Drug Advisory Committee, which voted five in favor and six opposed to the switch in November. 

January 9, 2013

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 4, 2013

The March of Dimes is launching a campaign to encourage expectant mothers to take folic acid to prevent birth defects, the group said Friday.

WHITE PLAINS, N.Y. — The March of Dimes is launching a campaign to encourage expectant mothers to take folic acid to prevent birth defects, the group said Friday.

The group announced national Folic Acid Awareness Week, reminding pregnant women to take vitamin B. The vitamin is known to prevent birth defects like spina bifida and anencephaly, collectively known as neural tube defects. NTDs occur in the first few weeks following conception, often before a woman knows she is pregnant.

January 3, 2013

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

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 20, 2012

Canadian regulators have allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.

NEW YORK — Canada's federal government has allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.

The Associated Press reported that Canadian health minister Leona Aglukkaq turned down requests from provincial and aboriginal tribal authorities to delay approval of a generic version of Purdue Pharma's OxyContin (oxycodone). OxyContin will lose its patent protection in Canada on Sunday.

November 13, 2012

The launch of a tamper-resistant formulation of a popular opioid painkiller in the United States, but not in Canada, may have influenced a spike in dispensing rate of the original at pharmacies in Canadian border cities, according to a study.

NEW YORK — The launch of a tamper-resistant formulation of a popular opioid painkiller in the United States, but not in Canada, may have influenced a spike in dispensing rate of the original at pharmacies in Canadian border cities, according to a study.

October 29, 2012

Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

WOODCLIFF LAKE, N.J. – Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.