Content about Pharmaceuticals policy

November 15, 2012
FDA panel advises against Merck's Oxytrol patch Rx-to-OTC switch application

The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention.

SILVER SPRING, Md. — The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention. 

The committee voted five in favor and six opposed, also citing concerns that men might inappropriately choose to use the product as well. 

November 15, 2012
Generic drugs compete in game of differentiation

The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


November 15, 2012
NABP report: Rogue pharmacies prolific

At some point in their lives, most people learn the old lesson about things that look too good to be true, sometimes by hearing it from others, and other times from 
bad experiences.


At some point in their lives, most people learn the old lesson about things that look too good to be true, sometimes by hearing it from others, and other times from 
bad experiences.


November 15, 2012
NewsBytes — Chain Pharmacy, 11/19/12

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.


The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.



 

November 15, 2012
OTC use on rise as self-care trend grows

Over-the-counter medications continue to gain in popularity among consumers, who — whether as a matter of cost savings or convenience — are increasingly turning to OTCs to treat their conditions, including both acute, episodic conditions like the common cold and such chronic conditions as frequent pain and allergy. 


Over-the-counter medications continue to gain in popularity among consumers, who — whether as a matter of cost savings or convenience — are increasingly turning to OTCs to treat their conditions, including both acute, episodic conditions like the common cold and such chronic conditions as frequent pain and allergy. 


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November 13, 2012
Reports: AMA supports legislation against 'pay-for-delay' deals

The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

NEW YORK — The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

Forbes reported that the AMA would support federal legislation to ban so-called "pay-for-delay" settlements. The AMA joins the Federal Trade Commission, which has strongly criticized the settlements

November 12, 2012
Reports: CVS Caremark drops 17 drugs from formulary

The PBM division of CVS Caremark is hoping to get patients to use lower-cost drugs for certain conditions by removing higher-cost drugs from its formulary, according to published reports.

NEW YORK — The PBM division of CVS Caremark is hoping to get patients to use lower-cost drugs for certain conditions by removing higher-cost drugs from its formulary, according to published reports.

The Wall Street Journal reported that CVS Caremark would stop covering 17 drugs starting on Jan. 1, 2013, after removing 30 this year. The drugs include Abbott's Androgel (testosterone gel) for low testosterone, and Pfizer's drug Detrol LA (tolterodine tartrate) for overactive bladder.

November 12, 2012
Reports: P&G, Teva partner on European OTC company called PGT Healthcare, gain EU approval

Procter & Gamble and Teva Pharmaceutical on Monday gained European Union approval for a joint venture on the sale of nonprescription medicines to be called PGT Healthcare, according to published reports.

CINCINNATI — Procter & Gamble and Teva Pharmaceutical on Monday gained European Union approval for a joint venture on the sale of nonprescription medicines to be called PGT Healthcare, according to published reports. 

According to the reports, the joint venture didn't raise competition concerns. P&G will have a 51% stake in the venture. 

 

 

November 9, 2012
Drugs for a penny? It's all about volume

Earlier this week, DSN reported that members of a prescription drug program offered by Humana to Medicare beneficiaries will soon be able to obtain 10 generic hypertension drugs from Walmart for a penny.

It's certainly good news for people with high blood pressure, but it also has big implications for the pharmacy retail industry.

Earlier this week, DSN reported that members of a prescription drug program offered by Humana to Medicare beneficiaries will soon be able to obtain 10 generic hypertension drugs from Walmart for a penny.

It's certainly good news for people with high blood pressure, but it also has big implications for the pharmacy retail industry.

November 8, 2012
Perrigo chief: Store brands big driver behind OTC growth, prepping launch of Mucinex equivalent

Business for OTC store brands is expected to boom in the coming year, Perrigo chairman and CEO Joseph Papa told analysts discussing the private-label manufacturer's first quarter results during a conference call Wednesday, even as the growth rate across the entire OTC category slows.

ALLEGAN. Mich. — Business for OTC store brands is expected to boom in the coming year, Perrigo chairman and CEO Joseph Papa told analysts discussing the private-label manufacturer's first-quarter results during a conference call Wednesday, even as the growth rate across the entire OTC category slows. "What we are seeing though, is the continued acceleration of store brand as being the reason why we're seeing the growth in our OTC category. For us to have a 9.4% growth in our OTC category, we think is a strong indication," Papa said. 

November 7, 2012
Study: OTC abuse higher among adolescent males

A recent University of Cincinnati study suggested adolescent males are at a higher risk of reporting longtime abuse of over-the-counter drugs, compared with their female peers.

SAN FRANCISCO — A recent University of Cincinnati study suggested adolescent males are at a higher risk of reporting longtime abuse of over-the-counter drugs, compared with their female peers. 

November 6, 2012
Pa. governor signs legislation enabling indie pharmacies to match reimbursement terms of mail order

Pennsylvania Gov. Tom Corbett last week signed into law S.B. 201, a bill that takes critical steps toward leveling the playing field between large pharmacy benefit managers and the mail-order pharmacies they own and local, independent community pharmacies.

ALEXANDRIA, Va. — Pennsylvania Gov. Tom Corbett last week signed into law S.B. 201, a bill that takes critical steps toward leveling the playing field between large pharmacy benefit managers and the mail-order pharmacies they own and local, independent community pharmacies. The legislation was applauded by community pharmacists. 

November 5, 2012
CACDS show includes prescription-ordering kiosk

Industry leaders at an annual retail pharmacy conference in Canada got a look at a kiosk that allows patients to order prescription drugs through an Internet connection.

TORONTO — Industry leaders at an annual retail pharmacy conference in Canada got a look at a kiosk that allows patients to order prescription drugs through an Internet connection.

TCE Group announced the introduction of its Pharma Kiosk, or PK+ terminal at the annual meeting of the Canadian Association of Chain Drug Stores in Toronto.

November 5, 2012
NewsBytes — Chain Pharmacy, 11/5/12

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

FDA approves cardiovascular drug

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain. Actavis announced the approval of diltiazem hydrochloride extended-release capsules.
The drug is a generic version of Valeant’s Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.



November 5, 2012
Watson-Actavis latest among generic M&As

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis.

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis. Watson announced the $5.6 billion acquisition of Actavis in April, a deal that is expected to make Watson the third-largest generic drug maker in the world, after Teva Pharmaceutical Industries and Mylan.

November 1, 2012
Reports: Generic extended-release drugs to get more attention from FDA

Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

October 31, 2012
Watson sells Rugby OTC business to Harvard Drug Group for $117 million

Watson Pharmaceuticals on Wednesday announced the sale of its Rugby over-the-counter business to the Harvard Drug Group — a distributor and provider of private-label OTCs and generic prescription products under the Major Pharmaceuticals brand — for approximately $117 million.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Wednesday announced the sale of its Rugby over-the-counter business to the Harvard Drug Group — a distributor and provider of private-label OTCs and generic prescription products under the Major Pharmaceuticals brand — for approximately $117 million.  

"I am confident that Major, with its leadership position as a marketer of OTC products, will be more strategically positioned to maximize the value of the long-known and respected Rugby name," stated Paul Bisaro, president and CEO of Watson.

October 29, 2012
Par acquires rights to generic version of Seroquel XR

Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

WOODCLIFF LAKE, N.J. – Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

October 29, 2012
Vast majority of online pharmacies are fly-by-night operations, report finds

About 97% of online pharmacies are "rogue" operations operating outside U.S. laws and regulations, according to a new report.

MOUNT PROSPECT, Ill. — About 97% of online pharmacies are "rogue" operations operating outside U.S. laws and regulations, according to a new report.

October 29, 2012
Watson launches generic version of Actos

The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

PARSIPPANY, N.J. – The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

Watson announced the launch of pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period ended in August, according to IMS Health.

October 25, 2012
FDA approves Par leukemia drug

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

Par said Thursday that the FDA had approved Anchen Pharmaceuticals' tretinoin capsules in the 10-mg strength.

The drug is a generic version of Roche's Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.

October 24, 2012
Mylan hopes to stop Watson launch of diabetes drug

Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

PITTSBURGH — Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

The generic drug maker said it filed a motion in the U.S. District Court for the District of Columbia Tuesday to stay the court's order, which called on the FDA to let Watson launch a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone).

October 23, 2012
United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval

The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

October 22, 2012
NCPA urges Pa. governor to approve state pharmacy bill

A group that lobbies on behalf of independent pharmacies is urging Pennsylvania Gov. Tom Corbett to sign a bill that would allow retail pharmacies to match the reimbursement terms, pricing and conditions that mail-order pharmacies negotiate exclusively with health insurance plans.

ALEXANDRIA, Va. — A group that lobbies on behalf of independent pharmacies is urging Pennsylvania Gov. Tom Corbett to sign a bill that would allow retail pharmacies to match the reimbursement terms, pricing and conditions that mail-order pharmacies negotiate exclusively with health insurance plans.

The National Community Pharmacists Association expressed hopes that Corbett would sign S.B. 201, which the Pennsylvania state Senate and House have unanimously approved.

October 22, 2012
Watson, Actavis divest more drugs as condition for FTC merger approval

Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.

NEW YORK – Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.