Showing posts with label version. Show all posts
Showing posts with label version. Show all posts

Tuesday, June 4, 2013

BRIEF-Glenmark Generics confirms patent challenge for its generic version of FINACEA

March 14 (Reuters) - Glenmark Pharmaceuticals Ltd :

* Glenmark confirms patent challenge for its generic version of FINACEA

* Intendis,Intraserv and Bayer Healthcare filed suit against Glenmark Generics

seeking to prevent sales of ANDA product

* Source text: * Further company coverage

((Bangalore Newsroom; +91 4135 5800))


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Saturday, May 4, 2013

The Nine Republican Men Who Won’t Consider Any Version Of The Violence Against Women Act

Nine Congressmen — all male Republicans — voted Wednesday against a resolution to allow the U.S. House to consider re-authorization of the Violence Against Women Act (VAWA). The vast majority of House Republicans (214) and all 200 House Democrats voted for rule, which will allow votes Thursday on the watered-down GOP version of the bill and (assuming that fails), the bipartisan Senate plan.

The nine Republicans were Representatives Paul Broun (GA), Scott Garrett (NJ), Louie Gohmert (TX), Tim Huelskamp (KS), Walter Jones (NC), Steve King (IA), Thomas Massie (KY), Tom McClintock (CA), and Matt Salmon (AZ).

Three of the nine — Gohmert, Jones, and King — voted for the watered-down Republican version of the bill last May, making their opposition to even bringing up the bill now a surprise. King said of the 2012 bill, “I supported VAWA in 2005 and am doing so again to see to it that victims of domestic violence and sexual assault have access to the resources and protection when they need it the most.”

While apparently none of the opponents has released a statement on today’s vote, some explained their opposition to last year’s bill. Huelskamp, in a letter to constituents, noted that he does not believe the federal government has a role in funding protection against domestic abuse. “This is a matter that should be left to our states,” he wrote, and Congress “should not be in the business of handing out grants conditioned on how states do or do not prosecute criminals.”

McClintock, in explaining his 2012 vote against VAWA, argued: “This is a feel-good measure that uses ‘Violence Against Women’ as an excuse to vastly expand a dizzying array of government grant programs, hamstring judges who are attempting to resolve and reconcile highly volatile relationships, add $1.8 billion to the nation’s debt and generally insinuate the federal government into matters the Constitution clearly reserves to the states. Federal grants of all kinds (essentially gifts of public money with little or no oversight) are out of control and ought to be abolished — not expanded.”

The landmark 1994 law, authored by then-Senator Joe Biden, expired more than a year ago.


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Friday, February 22, 2013

UPDATE 1-FDA OKs Merck OTC version of overactive bladder drug

Jan 25 (Reuters) - U.S. health regulators approved Merck & Co's nonprescription version of Oxytrol to treat overactive bladder in women ages 18 and older, the agency said on Friday.

The U.S. Food and Drug Administration said the over-the-counter version of Oxytrol would be available for women only and that the drug remained available to men by prescription.

Overactive bladder, which affects an estimated 33 million Americans, is a condition in which the bladder squeezes too often or without warning. Symptoms include leaking urine, feeling a sudden and urgent need to urinate, and frequent urination.

Oxytrol for Women is a patch that contains oxybutynin, a medicine that helps relax the bladder muscle, and is designed to be applied to the skin every four days, the FDA said.

Oxybutynin belongs to a class of drugs known as anticholinergics. Pfizer Inc's Detrol is the market leader in the class with annual sales of about $700 million.

Oxytrol will be the first drug in the class to be sold over the counter. Merck licensed exclusive rights to sell OTC Oxytrol from Actavis Inc, the generic drugmaker formerly known as Watson Pharmaceuticals.

Merck said it expected the OTC patch to be available in the fall.

The FDA decided to approve the OTC version of the Merck drug, based on the results of nine studies of women that demonstrated that consumers can understand the information on the label, properly determine whether the product is right for them, and use the drug appropriately, the agency said.

Last week, the FDA approved the popular wrinkle treatment Botox from Allergan Inc to treat overactive bladder in people who cannot tolerate drugs from the class to which Oxytrol belongs or are not helped by these medications.

Merck shares rose 3 cents to $43.03 on the New York Stock Exchange.


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