Content about Salix Pharmaceuticals

February 4, 2014

Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

RALEIGH, N.C. — Salix Pharmaceuticals last week announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

The FDA has issued an action date of Sept. 15, 2014 under the Prescription Drug User Fee Act. 

January 3, 2014

Salix Pharmaceuticals has completed its $2.6 billion acquisition of Santarus, Salix said.

RALEIGH, N.C. — Salix Pharmaceuticals has completed its $2.6 billion acquisition of Santarus, Salix said.

The drug maker announced that it had completed the $32-per-share acquisition of Santarus, which the companies announced in November. The combination of the companies' product portfolios includes 22 marketed products, such as Xifaxan, Glumetza, Zegerid, Relistor and others.

November 8, 2013

Salix Pharmaceuticals will buy Santarus for $2.6 billion, the drug makers said.

RALEIGH, N.C. — Salix Pharmaceuticals will buy Santarus for $2.6 billion, the drug makers said.

Salix will acquire all outstanding common stock of Santarus for $32 in cash, representing an approximately 36% premium over the Wednesday closing price of the company. The acquisition is expected to close in first quarter 2014. Both companies specialize in gastrointestinal drugs.

September 5, 2012

The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

RALEIGH, N.C. — The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

Salix Pharmaceuticals said the FDA was still reviewing its application for crofelemer in the 125-mg strength. The agency was originally expected to take action on the drug Wednesday. Crofelemer is meant for treating noninfectious diarrhea in HIV and AIDS patients taking antiretroviral therapy.

November 9, 2011

Salix Pharmaceuticals has entered a definitive agreement to acquire all outstanding stock of a provider of gastroenterology and urology therapeutics.

RALEIGH, N.C. — Salix Pharmaceuticals has entered a definitive agreement to acquire all outstanding stock of a provider of gastroenterology and urology therapeutics.

Salix said its acquisition of Oceana Therapeutics' outstanding stock is valued at $300 million in cash. The transaction is subject to customary conditions to closing (including U.S. antitrust approval) and is expected to be completed in December.

August 30, 2011

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.

May 9, 2011

Napo Pharmaceuticals has filed a lawsuit against Salix Pharmaceuticals, alleging that the latter breached commitments under an agreement to develop and commercialize a proprietary gastrointestinal compound.

RALEIGH, N.C. — Napo Pharmaceuticals has filed a lawsuit against Salix Pharmaceuticals, alleging that the latter breached commitments under an agreement to develop and commercialize a proprietary gastrointestinal compound.

Salix said that Napo's claims over its collaboration agreement concerning the development of crofelemer are without merit, adding that the drug maker plans to continue with the development and commercialization of crofelemer, in accordance with its past guidance and the terms of its collaboration agreement with Napo.

April 20, 2011

The U.S. Patent and Trademark Office has awarded Salix Pharmaceuticals three patents related to a drug used for travelers’ diarrhea.

RALEIGH, N.C. — The U.S. Patent and Trademark Office has awarded Salix Pharmaceuticals three patents related to a drug used for travelers’ diarrhea.

Salix announced Wednesday that it had secured patents for the drug Xifaxan (rifaximin) covering its methods of treating travelers’ diarrhea, as well as two related to the drug’s chemical composition.

The patents are set to expire between 2024 and 2029.

April 6, 2011

Indian drug maker Lupin and U.S. drug maker Salix Pharmaceuticals announced Wednesday a licensing deal for technology related to a drug for traveler’s diarrhea.

RALEIGH, N.C. — Indian drug maker Lupin and U.S. drug maker Salix Pharmaceuticals announced Wednesday a licensing deal for technology related to a drug for traveler’s diarrhea.

Under the deal, Salix will receive exclusive worldwide rights for Xifaxan (rifaximin) drug technology developed by Lupin and jointly by both companies in all countries except India.

Salix is required to pay Lupin $10 million upfront, as well as potential payments related to regulatory milestones.

March 8, 2011

The Food and Drug Administration declined to approve a drug made by Salix Pharmaceuticals for irritable bowel syndrome, Salix said Tuesday.

RALEIGH, N.C. — The Food and Drug Administration declined to approve a drug made by Salix Pharmaceuticals for irritable bowel syndrome, Salix said Tuesday.

The FDA issued a complete response letter to Salix for Xifaxan (rifaximin), a treatment for nonconstipation IBS and IBS-related bloating. Salix said it had anticipated that it would receive the letter based on an understanding that the agency needed more information related to retreatment.

February 7, 2011

Salix Pharmaceuticals and Progenics Pharmaceuticals have entered a licensing agreement for a drug used to treat side effects of opioid use.

TARRYTOWN, N.Y. — Salix Pharmaceuticals and Progenics Pharmaceuticals have entered a licensing agreement for a drug used to treat side effects of opioid use.

The two companies signed the agreement for Relistor (methylnaltrexone bromide), an injected drug used to treat opioid-induced constipation in patients for whom laxatives haven’t worked.

May 19, 2010

The U.S. Patent and Trademark Office has issued a patent to Salix Pharmaceuticals for a...