Content about Regulatory and Washington

June 27, 2011
Abbott Diabetes Care reports blood-glucose monitoring products stolen

Abbott Diabetes Care reported Friday that a shipment of blood-glucose monitoring products was reported stolen from a shipping carrier facility in Louisville, Ky., on June 19.

ALAMEDA, Calif. — Abbott Diabetes Care reported Friday that a shipment of blood-glucose monitoring products was reported stolen from a shipping carrier facility in Louisville, Ky., on June 19.

June 27, 2011
FDA accepts regulatory filing for Prochieve

The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

LIVINGSTON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

Columbia Labs and Watson Pharmaceuticals announced Monday that the FDA would review their application for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the third trimester of pregnancy.

June 24, 2011
FDA accepts Endo's resubmission for Opana ER

The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.

June 24, 2011
FDA panel recommends approval of Shire's Firazyr

A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.

DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.

Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.

HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.

June 24, 2011
Mylan's generic Entocort EC to enter market

A generic drug made by Mylan for Crohn’s disease does not infringe on the patent for the branded drug, a federal court ruled Thursday.

PITTSBURGH — A generic drug made by Mylan for Crohn’s disease does not infringe on the patent for the branded drug, a federal court ruled Thursday.

Mylan said the U.S. District Court for the District of Delaware ruled that Mylan’s regulatory approval application for budesonide capsules in the 3-mg strength does not violate the patent for the branded drug, AstraZeneca’s Entocort EC.

June 24, 2011
Pfizer receives complete response letter for Remoxy

The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

NEW YORK — The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

The FDA issued a complete response letter for Remoxy (oxycodone) extended-release capsules, which Pfizer is developing under a partnership with Pain Therapeutics. Pain Therapeutics originally developed the drug using Durect’s Oradur technology, which is designed to prevent tampering by drug abusers, in collaboration with King Pharmaceuticals. Pfizer took control of development of the drug when it acquired King in February.

June 23, 2011
Medicare and Medicaid FAST Act takes aim at cutting waste, fraud and abuse

Bipartisan legislation that is aimed to eliminate waste, fraud and abuse in Medicare and Medicaid programs has been introduced to Congress.

ALEXANDRIA, Va. — Bipartisan legislation that is aimed to eliminate waste, fraud and abuse in Medicare and Medicaid programs has been introduced to Congress.

Sens. Tom Carper, D-Del., and Tom Coburn, R-Okla., said that the Medicare and Medicaid Fighting Fraud and Abuse to Save Taxpayers’ Dollars Act, which was unveiled Wednesday, would address the aforementioned problems, which often lead to tens of billions of dollars lost to waste and fraud in Medicare and Medicaid every year, the senators said.

June 23, 2011
Supreme Court strikes down Rx data mining law

The Supreme Court has struck down a law in Vermont designed to encourage generic drug usage by limiting the sharing of information about what branded drugs doctors prescribe, so that drug companies could use it when crafting sales pitches, according to published reports.

WASHINGTON — The Supreme Court has struck down a law in Vermont designed to encourage generic drug usage by limiting the sharing of information about what branded drugs doctors prescribe, so that drug companies could use it when crafting sales pitches, according to published reports.

June 23, 2011
Wockhardt gets green light for three products

Wockhardt has launched three new drugs in the United States over the last three weeks, the Indian generic drug maker said.

MUMBAI, India — Wockhardt has launched three new drugs in the United States over the last three weeks, the Indian generic drug maker said.

Wockhardt announced the Food and Drug Administration's approval and the launch of the company's antibacterial drug levofloxacin, a generic version of Johnson & Johnson’s Levaquin, in the 250-mg, 500-mg and 750-mg strengths.

June 22, 2011
Dr. Reddy's brings generic Levaquin to market

Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

HYDERABAD, India — Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

The company said its levofloxacin tablets in the 250-mg, 500-mg and 750-mg strengths have entered the market, following the Food and Drug Administration's approval of Dr. Reddy's abbreviated new drug application. Dr. Reddy's levofloxacin tablets in the 250-mg and 500-mg strengths are available in 50-count bottles, while the 750-mg strength bottle is available in 30-count bottles.

June 22, 2011
NDEP updates website with new videos

The Department of Health and Human Services’ National Diabetes Education Program has unveiled a series of videos designed to help people make lifestyle changes and cope with the demands of diabetes.

WASHINGTON — The Department of Health and Human Services’ National Diabetes Education Program has unveiled a series of videos designed to help people make lifestyle changes and cope with the demands of diabetes.

June 22, 2011
New bill aims to help independent pharmacies to band together, negotiate prices for Rxs

Rep. Tom Marino, R-Pa., on Monday propositioned a bill that would allow independent drug stores to band together in an effort to increase their collective pharmaceutical buying power.

KINGSTON, Pa. — Rep. Tom Marino, R-Pa., on Monday propositioned a bill that would allow independent drug stores to band together in an effort to increase their collective pharmaceutical buying power.

June 22, 2011
Pfizer, Acura get FDA OK for Oxecta

The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

NEW YORK — The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

Pfizer and Acura Pharmaceuticals said that their drug Oxecta (oxycodone HCl, USP tablets) is the first tamper-resistant medication designed to deter abuse and misuse with Aversion technology, which is being licensed by Pfizer from Acura.

June 22, 2011
ProStrakan receives FDA approval to market Rectiv

ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.

GALASHIELS, Scotland, and BEDMINSTER, N.J. — ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.

The drug maker, which is a subsidiary of Kyowa Hakko Kirin, said that it received regulatory approval for Rectiv (nitroglycerin) ointment 0.4%. Rectiv currently is the only FDA-approved prescription product for patients with this condition. ProStrakan expects Rectiv to be available in the United States in first quarter 2012.

June 21, 2011
FDA approves first generic versions of Levaquin

The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

SILVER SPRING, Md. — The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

June 21, 2011
FDA unveils final cigarette warning labels

The Department of Health and Human Services on Tuesday morning unveiled the nine graphic health warnings mandated by the Food and Drug Administration to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.

WASHINGTON — The Department of Health and Human Services on Tuesday morning unveiled the nine graphic health warnings mandated by the Food and Drug Administration to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.

The warnings represent the most significant changes to cigarette labels in more than 25 years and will affect everything from packaging to advertisements. The warnings are required to be placed on all cigarette packs, cartons and ads no later than September 2012.

June 21, 2011
NACDS gears up for 2011 Marketplace Conference

The National Association of Chain Drug Stores once again is offering retailers and suppliers the opportunity to meet and work together to bring new, innovative products to market.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores once again is offering retailers and suppliers the opportunity to meet and work together to bring new, innovative products to market.

NACDS' 2011 Marketplace Conference will unite industry leaders from drug, food, mass, dollar and specialty retail at the Boston Convention & Exhibition Center from June 25 to 28.

June 21, 2011
Watson seeks to commercialize generic Avodart

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

June 20, 2011
Abbott receives FDA approval for Lupron Depot

The Food and Drug Administration has approved a new formulation of an injectable drug made by Abbott for prostate cancer.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new formulation of an injectable drug made by Abbott for prostate cancer.

Abbott announced Monday the approval of a 45-mg, six-month formulation of Lupron Depot (leuprolide acetate) for advanced prostate cancer. Previous formulations have allowed patients to receive the drug every month or every three or four months.

June 20, 2011
Adherence, generics to reduce $403bn in waste

The latest drug trend report from pharmacy benefit manager Express Scripts estimated that if patients using maintenance medications used cheaper therapies when possible, adhered to their medication therapies and used home delivery, it could eliminate $403 billion in pharmacy waste every year.


June 20, 2011
FDA panel unanimously recommends approval of Eylea

A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.

June 20, 2011
J&J subsidiary recalls one lot of Risperdal, risperidone tablets

Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.

June 20, 2011
Mylan wins summary judgment pertaining to generic Copaxone

Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.

PITTSBURGH — Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.

The U.S. District Court for the Southern District of New York denied Teva’s motion for a summary judgment finding no inequitable conduct in relation to Copaxone (glatiramer acetate).

June 20, 2011
Script Your Future campaign pushes importance of adherence

The National Consumers League recently launched the Script Your Future initiative to raise awareness among patients about the impact of not taking their medications as prescribed, and now the first-of-its-kind campaign is kicking off in several markets around the country.



PROVIDENCE, R.I. — The National Consumers League recently launched the Script Your Future initiative to raise awareness among patients about the impact of not taking their medications as prescribed, and now the first-of-its-kind campaign is kicking off in several markets around the country.


Script Your Future is an important initiative, as 3-out-of-4 Americans fail to take their medications as prescribed by their doctors. This equates to an estimated $290 billion drain on the U.S. healthcare system each year — costs that are avoidable.


June 17, 2011
CDC: Retail settings become popular alternative for flu shots

Many adults across the United States opted to visit their local drug store or supermarket to receive their flu shot during the 2010-2011 influenza season, according to the Centers for Disease Control and Prevention's "Morbidity and Mortality Weekly Report."

ATLANTA — Many adults across the United States opted to visit their local drug store or supermarket to receive their flu shot during the 2010-2011 influenza season, according to the Centers for Disease Control and Prevention's "Morbidity and Mortality Weekly Report."