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March 28, 2014

Dr. Reddy's Labs announced that it has launched amlodipine besylate and atorvastatin calcium tablets, a generic version of Caduet.

HYDERABAD, India — Dr. Reddy's Labs announced that it has launched amlodipine besylate and atorvastatin calcium tablets, a generic version of Caduet.

The Caduet tablets brand and generic had sales in the United States of approximately $163 million MAT for the most recent 12 months ended January 2014, according to IMS Health.

March 6, 2014

McNeil Consumer Healthcare on Wednesday introduced a new form to the Zyrtec portfolio of allergy-relief products — an oral, dissolvable tablet.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Wednesday introduced a new form to the Zyrtec portfolio of allergy-relief products — an oral, dissolvable tablet. Delivering the same effective 24-hour relief, Zyrtec Dissolve Tabs are now available at all major retailers and pharmacies.

Zyrtec, the best-selling brand within the cold-allergy-sinus tablet category, generated $317.3 million for the 52 weeks ended Dec. 29, up 1.8% across total U.S. multi-outlet, according to IRI data. 

December 2, 2013

The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

NOIDA, India — The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

Jubilant announced the approval of quetiapine fumarate tablets in the 25-mg strength. The drug is a generic version of AstraZeneca's Seroquel.

Various versions of the drug have annual sales of about $59 million, according to IMS Health.

 

November 4, 2013

Drug maker UCB is seeking approval for one of its drugs as a standalone therapy for epilepsy.

ATLANTA — Drug maker UCB is seeking approval for one of its drugs as a stand-alone therapy for epilepsy.

The company said Monday that the Food and Drug Administration had accepted its regulatory approval application for Vimpat (lacosamide) for adult epilepsy patients with partial-onset seizures. The drug is already approved as an add-on therapy for partial-onset seizures in patients aged 17 and older.

October 15, 2013

Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

DUBLIN — Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

The generic drug maker said it had filed a regulatory approval application with the Food and Drug Administration for buprenorphine hydrochloride and naloxone hydrochloride sublingual film in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The drug is a generic version of Reckitt Benckiser's Suboxone.

September 13, 2013

Actavis has launched a generic version of an extended-release opioid painkiller, the company said.

PARSIPPANY, N.J. — Actavis has launched a generic version of an extended-release opioid painkiller, the company said.

The drug maker announced the launch of oxymorphone extended-release tablets in the 5-mg, 10-mg, 20-mg, 30-mg and 40-mg strengths. Actavis received approval for the drug in July.

The drug is a generic version of Endo's Opana ER. Endo is currently suing Actavis, alleging that Actavis' generic infringes some of its patents. The drug is used for around-the-clock pain relief.

September 10, 2013

Perrigo announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored, the store brand equivalent to Children's Zyrtec Allergy Syrup.

ALLEGAN, Mich. — Perrigo on Tuesday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored, the store brand equivalent to Children's Zyrtec Allergy Syrup. Perrigo expects to begin shipments of the product during the upcoming cough/cold/flu season.

August 19, 2013

Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

LAKE SUCCESS, N.Y. — Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

CareMed said it had been selected to supply the drug, Tarceva (erlotinib). The two drug makers stopped distributing the drug, a once-daily treatment for advanced lung cancer, through retail pharmacies at the beginning of July.

July 24, 2013

Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said.

PITTSBURGH — Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said Wednesday.

Mylan said it had entered an agreement with Pfizer, Genentech and OSI that would allow their suit against Mylan over the drug Tarceva (erlotinib) to be dismissed. All other terms and conditions of the settlement are confidential, and the agreement is subject to Department of Justice and Federal Trade Commission review, Mylan said.

July 15, 2013

The Food and Drug Administration has approved a generic opioid painkiller made by Actavis, the drug maker said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic opioid painkiller made by Actavis, the drug maker said.

July 2, 2013

A cancer drug made by Genentech and Astellas is no longer available through ordinary retail channels and is now available only through a limited-distribution network.

NEW YORK — A cancer drug made by Genentech and Astellas is no longer available through ordinary retail channels and is now available only through a limited-distribution network.

Cancer-focused specialty pharmacy Onco360 said that effective Monday, the drug Tarceva (erlotinib) would no longer be available through retail pharmacies and that had joined a limited-distribution network that the drug makers had set up for the drug. Tarceva is used for treating advanced non-small cell lung cancer and pancreatic cancer.

May 22, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Sandoz, the company said.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic heart-disease drug made by Sandoz, the company said Wednesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of candesartan cilexetil tablets, a generic version of AstraZeneca's Atacand.

The drug is used to treat some types of heart failure in adults with left ventricular systolic dysfunction, as well as high blood pressure in adults and children as young as 1.

Atacand had sales of $120.3 million in 2012, according to IMS Health.

April 22, 2013

The Food and Drug Administration has approved a drug made by Alcon, the drug maker said.

BASEL, Switzerland — The Food and Drug Administration has approved a drug made by Alcon, the drug maker said.

April 9, 2013

The Food and Drug Administration has approved a drug for treating nausea and vomiting during pregnancy.

ROSEMONT, Pa. — The Food and Drug Administration has approved a drug for treating nausea and vomiting during pregnancy.

Drug maker Duchesnay USA said the FDA approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets in the 10 mg/10 mg strength for NVP, more commonly known as morning sickness, in women who don't respond to conservative treatment. NVP is estimated to affect 70-85% of pregnant women, and symptoms range from nausea to severe vomiting and retching that can last throughout the day.

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 3, 2013

The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said.

MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said Wednesday.

Tris announced the approval of Karbinal ER (carbinoxamine maleate) extended-release oral suspension in the 4 mg-per-five milliliter strength. The company said the drug was the first sustained-release histamine receptor blocking agent for seasonal and perennial allergic rhinitis in children 2 and older.

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 14, 2013

The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval and shipment of fluvoxamine maleate extended-release capsules in the 100-mg and 150-mg strengths. The drug is a generic version of Jazz Pharmaceuticals' Luvox CR.

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.

 

February 19, 2013

Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter, the company said.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter in some vials, the company said.

Gilead announced the voluntary recall of lot B120217A of Vistide (cidofovir), an injected drug used to treat cytomegalovirus retinitis in patients with AIDS, due to particulate matter.

January 24, 2013

Canadian pharmacy retailer Rexall has unveiled its new flagship private brand, Be.better, a line of more than 100 products available exclusively at the more than 300 corporate Rexall and Rexall Pharma Plus stores.

MISSISSAUGA, Ontario — Canadian pharmacy retailer Rexall has unveiled its new flagship private brand, Be.better, a line of more than 100 products available exclusively at the more than 300 corporate Rexall and Rexall Pharma Plus stores.

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.

December 6, 2012

Par Pharmaceutical Cos. has contracted with AstraZeneca to distribute an authorized generic version of a drug used to treat high blood pressure, Par said.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical Cos. has contracted with AstraZeneca to distribute an authorized generic version of a drug used to treat high blood pressure, Par said.

Par announced that it had entered a supply and distribution agreement through subsidiary Par Pharmaceutical to distribute an authorized generic version of Atacand HCT (i.e., candesartan cilexetil and hydrochlorothiazide) tablets.

An authorized generic is a branded drug marketed under its generic name at a discounted price, usually through a third-party company.

September 11, 2012

Generic drug maker Dr. Reddy's Labs has launched a generic drug for treating high blood pressure, the company said.

HYDERABAD, India — Generic drug maker Dr. Reddy's Labs has launched a generic drug for treating high blood pressure, the company said.

Dr. Reddy's announced the launch of metoprolol succinate extended-release tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths. The drug will be available in bottle counts of 100 and 500.

The drug is a generic version of AstraZeneca's Toprol-XL, branded and generic versions of which had sales of about $1.13 billion during the 12-month period that ended in June, according to IMS Health.

September 7, 2012

A Takeda drug designed to treat hypertension was statistically superior to another drug combination in reducing systolic blood pressure among patients in a 10-week, late-stage clinical trial.

DEERFIELD, Ill. — A Takeda drug designed to treat hypertension was statistically superior to another drug combination in reducing systolic blood pressure among patients in a 10-week, late-stage clinical trial.