Content about Piperazines

April 2, 2013

A ruling by India's high court means cheaper generic versions of a cancer drug will remain available in developing countries, according to published reports.

NEW YORK — A ruling by India's high court means cheaper generic versions of a cancer drug will remain available in developing countries, according to published reports.

The New York Times reported that the Indian Supreme Court ruled drug companies there could keep making generic versions of Swiss drug maker Novartis' leukemia medication Gleevec (imatinib). According to the Times, generic versions of Gleevec in India cost about $2,500 per year, compared with $70,000 per year for the branded version.

March 21, 2013

Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said.

NEW YORK — Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said Thursday.

Alcon announced the launch of Drops101 Web Tools, which offers access to information about two of its products: Ciprodex Otic (ciprofloxacin and dexamethasone), for acute otitis externa and acute otitis media in children with tymponostomy tubes; and Moxeza ophthalmic solution (moxifloxacin hydrochloride) for bacterial conjunctivitis.

March 21, 2013

The Food and Drug Administration advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients.

BETHESDA, Md. — The Food and Drug Administration on Thursday advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients. 

March 1, 2013

The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

TOKYO — The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

Otsuka Pharmaceutical and H. Lundbeck announced the FDA approval of Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation indicated for the treatment of schizophrenia.

The companies described Abilify Maintena as the first dopamine D2 partial agonist approved as a once-monthly injection, contributing to a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia.

January 25, 2013

The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

SILVER SPRING, Md. — The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

The FDA said Friday that it approved Gleevec (imatinib) for treating children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, also known as Ph+ ALL.

January 15, 2013

Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

NEW YORK — Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

Bloomberg reported that the Supreme Court upheld a ruling that allowed Otsuka to block Canadian generic drug maker Apotex from marketing a version of the antipsychotic Abilify (aripiprazole), which Otsuka co-markets with Bristol-Myers Squibb.

December 14, 2012

The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said Friday.

The FDA announced the approval of Iclusig (ponatinib) to treat chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, also known respectively as CML and Ph+ ALL.

December 12, 2012

The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

DEERFIELD, Ill. — The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

The FDA will review the companies' application for vortioxetine for the treatment of major depressive disorder in adults. The agency expects to finish reviewing the application by Oct. 2, 2013.

November 29, 2012

Watson Pharmaceuticals is changing its name to Actavis following its acquisition of the Swiss drug maker, Watson said.

Watson to change brand in 2013
PARSIPPANY, N.J. — Watson Pharmaceuticals is changing its name to Actavis following its acquisition of the Swiss drug maker, Watson said. Watson, whose $5.6 billion acquisition of Actavis received approval from the Federal Trade Commission in October, said it would adopt the new name starting in 2013, with plans to start a multi-year rebranding campaign and trade under a new symbol on the New York Stock Exchange.


November 29, 2012

In 2011 and 2012, the steady surge of blockbuster pharmaceuticals falling off the patent cliff became a stampede. An astonishing number of big-selling drugs that had established and sustained branded drug makers’ profits for years fell victim to the expiration of their patent lives and market exclusivity, roiling the pharmaceutical marketplace and redefining the pricing model for many of the most widely prescribed classes of medicines.


In 2011 and 2012, the steady surge of blockbuster pharmaceuticals falling off the patent cliff became a stampede. An astonishing number of big-selling drugs that had established and sustained branded drug makers’ profits for years fell victim to the expiration of their patent lives and market exclusivity, roiling the pharmaceutical marketplace and redefining the pricing model for many of the most widely prescribed classes of medicines.


November 13, 2012

The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

Mylan announced the FDA approval of sildenafil citrate tablets in the 20-mg strength, a generic version of Pfizer's Revatio. The drug is used to treat adults with PAH to improve exercise ability and delay clinical worsening of the condition.

Revatio had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

November 12, 2012

The Food and Drug Administration has approved a generic drug for pulmonary arterial hypertension made by Watson Pharmaceuticals, the drug maker said Monday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for pulmonary arterial hypertension made by Watson Pharmaceuticals, the drug maker said Monday.

Watson said the FDA approved its sildenafil tablets in the 20 mg strength through a subsidiary. Watson said it would launch the drug "in the near future."

The drug is a generic version of Pfizer's Revatio tablets, which had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

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.

October 26, 2012

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

October 2, 2012

Drug makers Takeda Pharmaceutical and H. Lundbeck have applied with the Food and Drug Administration for a new drug to treat depression in adults.

OSAKA, Japan — Drug makers Takeda Pharmaceutical and H. Lundbeck have applied with the Food and Drug Administration for a new drug to treat depression in adults.

Japan-based Takeda and Denmark-based Lundbeck announced the submission of a new drug application for Lu AA21004 (vortioxetine) for major depressive disorder.

September 21, 2012

The Food and Drug Administration has approved a generic drug for motion sickness made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for motion sickness made by Mylan.

The drug maker announced Friday that the FDA had approved meclizine hydrochloride tablets in the 12.5-mg, 25-mg and 50-mg strengths. Mylan said it would launch the drug immediately.

The drug is a generic version of Pfizer's Antivert, which is used to treat nausea, vomiting and dizziness associated with motion sickness. Antivert had sales of about $53.5 million during the 12-month period ended in June, according to IMS Health.

September 11, 2012

The Food and Drug Administration on Thursday issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group, of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group, of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.

September 5, 2012

The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

The FDA announced the approval of Pfizer's Bosulif (bosutinib) for chronic myelogenous leukemia, or CML. According to the FDA, about 5,430 men and women will be diagnosed with CML this year.

The drug is designed for patients with chronic, accelerated or blast-phase Philadelphia chromosome-positive CML, who can't tolerate other therapies or for whom those therapies don't work.

August 23, 2012

Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

PARSIPPANY, N.J. — Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

Wockhardt announced the tentative approval for ziprasidone hydrochloride in the 20 mg, 40 mg, 60 mg and 80 mg strengths, used to treat bipolar disorder and schizophrenia, and the company plans to launch the drug on Sept. 2, 2012.

June 18, 2012

Greenstone, the generic pharmaceutical subsidiary of Pfizer, has launched olanzapine tablets.

PEAPACK, N.J. — Greenstone, the generic pharmaceutical subsidiary of Pfizer, has launched olanzapine tablets.

The drug, which is a generic version of Zyprexa — an Eli Lilly drug used to treat psychiatric disorders — in the 2.5-mg, 5-mg, 7.5-mg, 10-mg, 15-mg and 20-mg strengths.

Generic and branded versions of the drug had sales of about $3.28 billion during the 12-month period ended in January, according to IMS Health.

June 4, 2012

An experimental drug made by Bayer HealthCare extended the length of time that patients with gastrointestinal tumors survived without their disease getting worse, according to results of a late-stage clinical trial released Monday.

WAYNE, N.J. — An experimental drug made by Bayer HealthCare extended the length of time that patients with gastrointestinal tumors survived without their disease getting worse, according to results of a late-stage clinical trial released Monday.

April 25, 2012

Sun Pharmaceutical Industries has launched a generic version of a drug used to treat psychiatric disorders, the company said.

MUMBAI, India — Sun Pharmaceutical Industries has launched a generic version of a drug used to treat psychiatric disorders, the company said.

Sun announced the launch of olanzapine tablets in the 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg strengths.

The drug is a generic version of Eli Lilly's Zyprexa, used to treat schizophrenia and bipolar disorder. The branded drug and generic versions had sales of $3.28 billion during the 12-month period ended in January, according to IMS Health.

 

April 24, 2012

Mylan has launched a generic drug for treating psychiatric disorders, the company said Tuesday.

PITTSBURGH — Mylan has launched a generic drug for treating psychiatric disorders, the company said Tuesday.

Mylan announced the launch of olanzapine tablets in the 2.5-mg, 5-mg, 7.5-mg, 10-mg, 15-mg and 20-mg strengths.

The drug, a generic version of Eli Lilly's Zyprexa, is used to treat schizophrenia and bipolar disorder. Various versions of the drug had sales of about $3.3 billion in 2011, according to IMS Health.

March 5, 2012

Indian drug maker Dr. Reddy's has launched a drug designed to treat bipolar disorder and schizophrenia, the company said.

HYDERABAD, India — Indian drug maker Dr. Reddy's has launched a drug designed to treat bipolar disorder and schizophrenia, the company said.

The company announced the launch of ziprasidone hydrochloride capsules in the 20-mg, 40-mg, 60-mg and 80-mg strengths.

The drug is a generic version of Pfizer's Geodon, which had sales of $1.34 billion in 2011, according to IMS Health.

February 3, 2012

Teva Pharmaceuticals has launched a generic version of a psychiatric drug, the company said Friday.

NORTH WALES, Pa. — Teva Pharmaceuticals has launched a generic version of a psychiatric drug, the company said Friday.

Teva announced the launch of olanzapine orally disintegrating tablets in the 5-mg, 10-mg, 15-mg and 20-mg strengths in blister packs of 30.

The drug is a generic version of Eli Lilly's Zyprexa Zydis, used to treat schizophrenia and bipolar disorder.


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