Content about Morpholines

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

According to the FDA's website, the agency granted the preliminary authorization for Roxane Labs' linezolid oral suspension in the 100-mg-per-5-mL strength.

November 15, 2012

Initial shipment of a generic appetite suppressant has started, the drug's manufacturer said Thursday.

NORTHVALE, N.J. — Initial shipment of a generic appetite suppressant has started, the drug's manufacturer said Thursday.

Elite Pharmaceuticals announced the initial shipment of phendimetrazine tartrate tablets in the 35-mg strength, a generic version of Valeant's Bontril PDM, under a manufacturing and supply agreement with Mikah Pharma. Actavis, recently acquired by Watson Pharmaceuticals, will distribute the drug as part of a distribution agreement between Mikah and Actavis.

May 24, 2012

A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.

RARITAN, N.J. — A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.

J&J subsidiary Janssen Research & Development said the FDA's Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of Xarelto (rivaroxaban) combined with antiplatelet drugs to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.

November 7, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

The agency announced Friday the approval of Xarelto (rivaroxaban), an anti-clotting made by J&J subsidiary Janssen Pharmaceuticals, in patients with non-valvular atrial fibrillation. The FDA approved the drug in the 10-mg strength in July for deep-vein thrombosis in patients receiving knee and hip replacement surgery. The latest approval includes 15-mg and 20-mg strengths.

December 9, 2010

An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

RIDGEFIELD, Conn. — An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

BI said the phase 2b/3 “LUX-Lung 1” trial of BIBW 2992 (afatinib) showed a fourfold increase in survival among advanced non-small cell lung cancer patients taking the drug versus those taking placebo, whose survival was extended by one month.

November 14, 2010

An investigational drug made by Johnson & Johnson is more effective in reducing the risk...

CHICAGO An investigational drug made by Johnson & Johnson is more effective in reducing the risk of stroke in patients with a trial fibrillation than a widely available generic, the drug maker said Monday.

J&J announced results of the phase-3 “Rocket-AF” trial of rivaroxaban, saying results showed that a once-daily dose of the drug worked better than warfarin, the most commonly used drug for preventing stroke in AF patients. Rivaroxaban also was comparable in terms of safety.

September 8, 2010

Hi-Tech Pharmacal had $40.4 million in sales during its fiscal first quarter ended July 31,...

AMITYVILLE, N.Y. Hi-Tech Pharmacal had $40.4 million in sales during its fiscal first quarter ended July 31, the generic drug maker said Thursday. The numbers amounted to a decrease of $3 million from the same period in 2009.