Content about Piperazines

March 18, 2014

Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday.

NEW YORK — Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday

Torrent has filed an aNDA with the Food and Drug Administration, challenging Pfizer's patent that expires on Oct. 22, 2019. 

March 13, 2014

Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

COLUMBIA, S.C. — Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

The research was published in the March/April issue of Annals of Family Medicine.

March 6, 2014

Lupin on Thursday announced that it received final approval from the Food and Drug Administration for both its doxycycline capsules and its ciprofloxacin for oral suspension.

MUMBAI and BALTIMORE — Lupin on Thursday announced that it received final approval from the Food and Drug Administration for its doxycycline capsules USP, 50 mg, 75 mg and 100 mg, which is the generic version of Aqua Pharmaceuticals' Monodox capsules. The drug is used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne, according to the company.

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. 

March 3, 2014

Teva Pharmaceutical Industries announced the launch of Adasuve (loxapine) inhalation powder in a 10-mg dosage. The drug is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of Adasuve (loxapine) inhalation powder in a 10-mg dosage. The drug is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.

February 13, 2014

Teva Pharmaceutical Industries announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

JERUSALEM — Teva Pharmaceutical Industries on Thursday announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

The drug is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

January 22, 2014

Takeda Pharmaceuticals and Lundbeck announced the availability of Brintellix (vortioxetine), a once-daily oral antidepressant for treatment of major depressive disorder in adults.

DEERFIELD, Ill. — Takeda Pharmaceuticals U.S.A. and Lundbeck on Tuesday announced the availability of Brintellix (vortioxetine) — a once-daily oral antidepressant for treatment of major depressive disorder in adults — in pharmacies across the United States.

“MDD continues to be a challenging condition to manage, and we are proud to make Brintellix available as a new treatment option for people struggling with major depression,” said Douglas Cole, president of Takeda Pharmaceuticals U.S.A.

December 23, 2013

The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

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

The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

October 8, 2013

Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.

BALTIMORE — Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.

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 6, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

Lupin said the FDA approved its ranolazine extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is used to treat chronic angina.

Ranolazine extended-release tablets are a generic version of Gilead Sciences' Ranexa, which had sales of about $443.4 million during the 12-month period that ended in March, according to IMS Health.

 

August 5, 2013

Amneal Pharmaceuticals has introduced five new generic drugs, the company said.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has introduced five new generic drugs, the company said.

The drugs launched are:

Potassium chloride extended-release capsules in the 750-mg strength and in bottle count sizes of 100, 500 and 1,000. The drug is a generic version of Nesher Pharmaceuticals' Micro-K10 ExtenCaps and used to treat potassium deficiency.

Sildenafil tablets in the 20-mg strength and in 90-count bottles. The drug is a generic version of Pfizer's Revatio, used to treat pulmonary arterial hypertension.

July 1, 2013

The Food and Drug Administration has approved a drug made by Sunovion and Dainippon Sumitomo Pharma Co. for bipolar disorder, Sunovion said.

MARLBOROUGH, Mass. — The Food and Drug Administration has approved a drug made by Sunovion and Dainippon Sumitomo Pharma Co. for bipolar disorder, Sunovion said Monday.

The FDA has approved Latuda (lurasidone hydrochloride) for use either alone or combined with lithium or valproate in patients with bipolar depression. The drug was already approved for treating schizophrenia.

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.