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October 29, 2013

Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

September 6, 2013

The Food and Drug Administration has approved a drug made by Celgene for treating patients with pancreatic cancer that has spread to other parts of the body, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Celgene for treating patients with pancreatic cancer that has spread to other parts of the body, the agency said Friday.

The FDA announced the approval of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) for patients with late-stage forms of the disease. The drug is a chemotherapy treatment already approved for treating breast and lung cancers.

September 28, 2012

Drug maker OncoGenex Pharmaceuticals has started its third late-stage clinical trial of a drug for treating a type of lung cancer.

BOTHELL, Wash. — Drug maker OncoGenex Pharmaceuticals has started its third late-stage clinical trial of a drug for treating a type of lung cancer.

OncoGenex announced Friday the initiation of the phase-3 "ENSPIRIT" trial of custirsen in patients with nonsmall cell lung cancer that has spread to other parts of the body, also known as metastasis, and whose disease has progressed after initial treatment with chemotherapy has failed.

September 28, 2011

Sagent Pharmaceuticals has launched its new chemotherapy drug.

SCHAUMBURG, Ill. — Sagent Pharmaceuticals has launched its new chemotherapy drug.

Sagent sent that its paclitaxel injection USP is available in 30-mg, 100-mg and 300-mg latex-free, multi-dose vials. Paclitaxel is indicated for use alone or with other drugs to treat ovarian cancer, breast cancer, non-small cell lung cancer and AIDS-related Kaposi's sarcoma, Sagent said.

August 23, 2011

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

PRINCETON, N.J. — The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval and launch of docetaxel, an injectable chemotherapy drug that the company said was the 11th cancer drug it has launched in the United States.

April 29, 2011

The Food and Drug Administration has approved a new treatment for prostate cancer made by Johnson & Johnson.

HORSHAM, Pa. — The Food and Drug Administration has approved a new treatment for prostate cancer made by Johnson & Johnson.

Centocor Ortho Biotech, J&J’s biotech subsidiary, announced Thursday the approval of Zytiga (abiraterone acetate), a daily pill for use in combination with the corticosteroid prednisone for treating castration-resistant prostate cancer that has spread to other parts of the body in men who have received prior chemotherapy with Sanofi-Aventis’ Taxotere (docetaxel).

March 10, 2011

Hospira has received approval from the Food and Drug Administration for a generic cancer treatment.

LAKE FOREST, Ill. — Hospira has received approval from the Food and Drug Administration for a generic cancer treatment.

Hospira will offer 20-mg, 80-mg and 160-mg vials of docetaxel at a 10-mg/mL concentration. Docetaxel is a generic version of Sanofi-Aventis's Taxotere.

Hospira already markets docetaxel in Europe and Australia, the drug maker noted.

January 6, 2011

The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

SAN DIEGO — The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

The FDA accepted AdventRx’s application for Exelbine (vinorelbine). The drug is a branded generic, being formulated with the same active ingredient as Navelbine, originally marketed by French drug maker Pierre Fabre and now available as a generic from seven companies.

December 8, 2010

Chemotherapy drugs made by Johnson & Johnson and Merck will become the standard second-line treatment for ovarian cancer within the decade, replacing a treatment made by Bristol-Myers Squibb and generic versions, according to a new report by market research firm Decision Resources.

BURLINGTON, Mass. — Chemotherapy drugs made by Johnson & Johnson and Merck will become the standard second-line treatment for ovarian cancer within the decade, replacing a treatment made by Bristol-Myers Squibb and generic versions, according to a new report by market research firm Decision Resources.

September 30, 2010

The Food and Drug Administration is cracking down on companies that sell an unapproved treatment...

September 30, 2010

Data published in the latest issue of medical journal The Lancet showed that a recently...

BRIDGEWATER, N.J. Data published in the latest issue of medical journal The Lancet showed that a recently approved drug reduced the risk of death in men with a certain form of prostate cancer by more than a quarter.