Content about Lactams

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 17, 2014

Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.

PRINCETON, N.J. and NEW YORK — Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.  

February 18, 2014

Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

MUMBAI — Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

January 21, 2014

Greenstone, a U.S.-based generic pharmaceutical subsidiary of Pfizer, on Tuesday announced the introduction of Sirolimus to its generic pharmaceutical product line.

PEAPACK, N.J. — Greenstone, a U.S.-based generic pharmaceutical subsidiary of Pfizer, on Tuesday announced the introduction of Sirolimus to its generic pharmaceutical product line. The product is offered in dosage strengths of 0.5mg x 100. 

Greenstone’s Sirolimus product is the authorized generic of, and equivalent to, Pfizer's Rapamune (sirolimus). 

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

The FDA granted tentative approval to Roxane Labs' dutasteride capsules in the 0.5-mg strength. The drug is a generic version of GSK's Avodart, used to treat benign prostatic hyperplasia.

Tentative approval means that a drug meets the agency's conditions for approval, but can't receive final approval until Avodart loses its patent protection, which will occur in 2015.

 

August 13, 2013

Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the Food and Drug Administration.

DEERFIELD, Ill. — Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the U.S. Food and Drug Administration. Onfi is a prescription medication originally approved by the FDA in 2011, and is used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 2 years of age or older. Onfi is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine.

August 12, 2013

Teva Pharmaceutical and Perrigo Co. announced the launch of the generic equivalent to Temodar (temozolomide). Teva will manufacture, market and distribute the product in the United States, and both companies will equally share in the cost and profitability of the product in the country.

JERUSALEM and ALLEGAN, Mich. — Teva Pharmaceutical Industries Ltd., and Perrigo Co. today announced the launch of the generic equivalent to Temodar (temozolomide). Teva will manufacture, market and distribute the product in the United States, and both companies will equally share in the cost and profitability of the product in the country. Teva was first to file, making the product eligible for 180 days of marketing exclusivity.

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 18, 2013

According to the Administration on Aging, the United States is similar to many other countries in the developed world — and even a few in the developing world — in that the population is getting older.

According to the Administration on Aging, the United States is similar to many other countries in the developed world — and even a few in the developing world — in that the population is getting older. According to the AOA, people in the United States ages 65 years and older numbered 39.6 million in 2009, a number expected to reach 72.1 million by 2030. In 2000, the elderly represented 12.4% of the population in the United States, but will constitute 19% of it in 17 years.

July 16, 2013

Men who took an erectile dysfunction drug made by Eli Lilly experienced normal erectile function when taking it once a day as opposed to taking erectile dysfunction treatment on an as-needed basis, according to a new study.

INDIANAPOLIS — Men who took an erectile dysfunction drug made by Eli Lilly experienced normal erectile function when taking it once a day as opposed to taking erectile dysfunction treatment on an as-needed basis, according to a new study.

The study, published in the Journal of Sexual Medicine, found a greater percentage of men who had an incomplete response to as-needed treatment with phosphodiesterase type 5, or PDE5 inhibitors, a drug class that includes Lilly's Cialis (tadalafil), compared with those who took Cialis once a day.

July 9, 2013

Amgen will get rights to a drug for cardiovascular disease approved in the European Union under a new deal with French drug maker Servier, the two companies said.

THOUSAND OAKS, Calif. — Amgen will get rights to a drug for cardiovascular disease approved in the European Union under a new deal with French drug maker Servier, the two companies said Tuesday.

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.

June 26, 2013

Teva Pharmaceutical Industries and Mylan have launched generic versions of Pfizer's Viagra in nearly a dozen European countries, the two companies said.

NEW YORK — Teva Pharmaceutical Industries and Mylan have launched generic versions of Pfizer's Viagra in nearly a dozen European countries, the two companies said.

Teva, based in Jerusalem, announced the launch of generic sildenafil tablets in Germany, the United Kingdom, Italy, the Netherlands, Switzerland, Ireland, Austria, Belgium and Denmark. The company already markets generic versions of the erectile dysfunction drug in Spain and Canada.

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.

February 14, 2013

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

February 7, 2013

An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

STAMFORD, Conn. — An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

The placebo-controlled study, published in the journal Sleep, tested the drug Intermezzo (zolpidem tartrate) sublingual tablets on 295 adults with primary insomnia and difficulty returning to sleep after waking up in the middle of the night. Purdue said Intermezzo was the only drug approved by the Food and Drug Administration for treating such patients.

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.

January 10, 2013

The Food and Drug Administration is ordering the makers of several sleep drugs to lower the dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.

January 3, 2013

Dr. Reddy's Labs has launched a generic drug for treating baldness, the Indian drug maker said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating baldness, the Indian drug maker said.

Dr. Reddy's announced the launch of finasteride tablets in the 1-mg strength, a generic version of Merck's Propecia. As the first company to successfully file for approval of a generic version of the drug, Dr. Reddy's is entitled to 180 days of market exclusivity in which to compete directly with the branded version.

Propecia had sales of about $136 million during the 12-month period that ended in October 2012, according to IMS Health.

January 2, 2013

The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

PRINCETON, N.J. — The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

December 28, 2012

Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

November 19, 2012

Dr. Reddy's Labs has launched a generic drug for treating pulmonary arterial hypertension, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating pulmonary arterial hypertension, the company said.

Dr. Reddy's announced the launch of sildenafil tablets in the 20 mg strength in 90-count bottles. The drug is a generic version of Pfizer's Revatio.

Revatio had sales of $338.67 million during the 12-month period ended in September, according to IMS Health.

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.