Content about Janssen Pharmaceutica

February 20, 2014

Kremers Urban Pharmaceuticals announced the launch of rabeprazole sodium delayed-release tablets, which are used to treat gastroesophageal reflux disease in adults and adolescents.

PRINCETON, N.J. — Kremers Urban Pharmaceuticals, a subsidiary of UCB, announced the launch of rabeprazole sodium delayed-release tablets. The drug is used to treat gastroesophageal reflux disease in adults and adolescents, according to the FDA.

The product is the bioequivalent to Aciphex from Eisai. Kremers Urban rabeprazole sodium delayed-release tablets are available in 20-mg strength in both 30- and 90-count bottles.

November 11, 2013

Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

BALTIMORE — Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

Lupin announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $864.3 million during the 12-month period that ended in June, according to IMS Health.

 

November 11, 2013

Mylan has launched its generic version of a drug used to treat gastroesophageal reflux disease, the U.S.-based generic drug maker said Monday.

PITTSBURGH — Mylan has launched its generic version of a drug used to treat gastroesophageal reflux disease, the U.S.-based generic drug maker said Monday.

Mylan announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $830.1 million during the 12-month period that ended in September, according to IMS Health. 

November 8, 2013

The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

The FDA announced the approval of the first generic versions of Eisai's Aciphex (rabeprazole sodium) delayed-release tablets for patients aged 12 and older. The generic products are made by Dr. Reddy's Labs, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals.

October 10, 2013

A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

TITUSVILLE, N.J. — A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

Janssen Pharmaceuticals announced that it had bought, for an undisclosed among, the drug GSK2336805 from GSK. The drug, which belongs to a class known as NS5a replication complex inhibitors, is currently in mid-stage development.

October 3, 2013

The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

SILVER SPRING, Md. — The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

July 8, 2013

Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

NEW YORK — Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

The FDA listed the guidelines on its website, saying that unused fentanyl patches should be stored out of the reach and sight of children, while used patches should be folded, sticky sides together, and flushed down the toilet.

May 23, 2013

Johnson & Johnson expects to file for Food and Drug Administration approval of more than 10 new drugs over the next four years, the drug maker said Thursday.

NEW BRUNSWICK, N.J. — Johnson & Johnson expects to file for Food and Drug Administration approval of more than 10 new drugs over the next four years, the drug maker said Thursday.

J&J's Janssen Pharmaceutical Cos. highlighted its more than 11 new product launches since 2009 and said it hoped to file with the FDA for more than two-dozen "significant" extensions to its branded drug lines by 2017.

April 24, 2013

Johnson & Johnson subsidiary Janssen has launched an interactive educational website about diabetes for European healthcare professionals.

BEERSE, Belgium — Johnson & Johnson subsidiary Janssen has launched an interactive educational website about diabetes for European healthcare professionals.

Dubbed the Janssen Diabetes Forum, the website is designed to educate users about the latest developments in the management of Type 2 diabetes. The website was launched Tuesday in Beerse, Belgium.

March 27, 2013

The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

Eisai announced the approval of Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules.

March 18, 2013

Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

LAKE OSWEGO, Ore. — Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

Galena, which specializes in cancer-related drugs, said it acquired Abstral (fentanyl) sublingual tablets for sale and distribution in the United States from Orexo AB. Breakthrough cancer pain, or BTcP, affects between 40% to 80% of cancer patients, with reported episodes of four per day and a median duration of 30 minutes, according to Galena.

December 4, 2012

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

Eisai said the FDA accepted its application for AcipHex delayed-release sprinkle capsules in the 5-mg and 10-mg strengths for healing of gastroesophageal reflux disease, and maintenance of healing of GERD and improvement of symptoms in children ages 1 year to 11 years.

The FDA expects to have the application reviewed by March 27, 2013. The drug is currently approved in the 20-mg strength for adolescents and adults.

August 23, 2012

A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

REDWOOD CITY, Calif. — A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

April 3, 2012

Forest Labs has bought rights to a drug used for high blood pressure that it had marketed with a Johnson & Johnson subsidiary, thus eliminating the need to pay future royalties.

NEW YORK — Forest Labs has bought rights to a drug used for high blood pressure that it had marketed with a Johnson & Johnson subsidiary, thus eliminating the need to pay future royalties.

Forest announced Monday that it had bought all U.S. and Canadian intellectual property related to Bystolic (nebivolol) for $357 million from Janssen Pharmaceutica NV on Friday.

March 14, 2012

Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

NEW YORK — Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV have sued Glenmark, Hetero USA, Torrent Pharmaceuticals and Watson Labs in response to their filing regulatory approval applications with the Food and Drug Administration for generic versions of Bystolic (nebivolol).

February 8, 2012

Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

PARSIPPANY, N.J. — Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

January 10, 2012

Shire has acquired U.S. rights to a drug used to treat chronic constipation in women from Johnson & Johnson, the company said Tuesday.

PHILADELPHIA — Shire has acquired U.S. rights to a drug used to treat chronic constipation in women from Johnson & Johnson, the company said Tuesday.

Shire announced the acquisition of rights to Resolor (prucalopride) from J&J subsidiary Janssen Pharmaceuticals. Financial terms were not disclosed.

Shire acquired European rights to the drug in 2010 when it bought Belgian drug maker Movetis, which itself had acquired rights to the drug from Janssen.

 

July 29, 2011

A generic version of a popular pneumonia treatment has entered the market from Hi-Tech Pharmacal.

AMITYVILLE, N.Y. — A generic version of a popular pneumonia treatment has entered the market from Hi-Tech Pharmacal.

Hi-Tech Pharmacal has introduced levofloxacin oral solution in the 25-mg/mL strength. The drug will be available in 480-mL, 200-mL and 100-mL sizes in order to allow pharmacists to tailor inventory to store volume. As previously reported by Drug Store News, Hi-Tech Pharmacal was granted tentative approval for the drug in April.

June 28, 2011

A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

CORK, Ireland — A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

Gilead and Tibotec Pharmaceuticals will work to create a once-daily, single-tablet combination of Tibotec’s Prezista (darunavir) and Gilead’s investigational drug cobicistat, a so-called boosting agent.

June 20, 2011

Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.

April 11, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

J&J said Monday that the FDA had approved Invega (paliperidone) extended-release tablets for patients ages 12 to 17 years. The drug is marketed by J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals. The drug originally was approved in 2006 for treating schizophrenia in adults.

November 1, 2010

Generic drug maker Watson Pharmaceuticals will distribute an authorized generic version of a drug used...

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals will distribute an authorized generic version of a drug used to treat attention deficit hyperactivity disorder, Watson said Tuesday.

Watson entered an agreement with Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals to distribute an authorized generic of Concerta (methylphenidate hydrochloride) extended-release tablets. An authorized generic is a branded drug sold under its generic name, usually by a third-party company.

May 23, 2010

Two subsidiaries of Johnson & Johnson will pay more than $81 million to the federal...