Content about Pharmaceuticals policy

November 20, 2013

Through mid-November, a national registry of over-the-counter drugs considered chemical precursors to methamphetamine prevented more than 16,700 boxes of the drugs from being sold illegally.

CHARLESTON, W.Va. — Through mid-November, a national registry of over-the-counter drugs considered chemical precursors to methamphetamine prevented more than 16,700 boxes of the drugs from being sold illegally.

November 18, 2013

Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

DUBLIN — Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

The generic drug maker it filed with the Food and Drug Administration for approval of testosterone topical solution in the 30-mg-per-1.5 mL strength, a generic version of Lilly's Axiron. The drug is used as a replacement therapy for deficient or absent testosterone.

November 15, 2013

The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

LONDON — The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

GW Pharmaceuticals said Friday that the FDA had granted the designation to Epidiolex for Dravet syndrome, a severe, drug-resistant form of epilepsy that begins in infancy. The drug is an oral liquid of a highly purified extract of cannabidiol, a non-psychoactive molecule derived from the cannabis plant.

November 14, 2013

The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert.

SILVER SPRING, Md. — The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert emailed Thursday. "We are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers," the alert stated. "The antiseptics in these single-use containers should be applied only one time to one patient.

November 13, 2013

Sohm on Tuesday announced the U.S. launch of its umbrella brand SohMed, positioning the company in the generic over-the-counter medicines segment for indications of pain, fever, cold, antacid and alertness.

BUENA PARK, Calif. — Sohm on Tuesday announced the U.S. launch of its umbrella brand SohMed, positioning the company in the generic over-the-counter medicines segment for indications of pain, fever, cold, antacid and alertness.

November 8, 2013

Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

Amneal said it would launch its version of 24 Fe (norethindrone acetate and ethinyl estradiol tablets; ferrous fumarate tablets) in the 1 mg/20 mcg and 75 mg strength. As the first company to successfully file for Food and Drug Administration approval of the drug, Amneal's product will have 180 days in which to compete exclusively against the branded version.

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 8, 2013

The United States is leading in its preference for generic drugs. According to a new report by Rhinebeck, N.Y.-based Phoenix Marketing International, 37% of American consumers expressed a preference for generic drugs when they were available, compared with 22% of the French, 21% of Canadians and 12% of Britons. The study was based on 810 consumers in the four countries.

The United States is leading in its preference for generic drugs. According to a new report by Rhinebeck, N.Y.-based Phoenix Marketing International, 37% of American consumers expressed a preference for generic drugs when they were available, compared with 22% of the French, 21% of Canadians and 12% of Britons. The study was based on 810 consumers in the four countries.

November 6, 2013

State legislators in Michigan are considering a bill that would allow pharmacies to sell medical marijuana, according to published reports.

NEW YORK — State legislators in Michigan are considering a bill that would allow pharmacies to sell medical marijuana, according to published reports.

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

 

November 1, 2013

Indian drug maker Dr. Reddy's Labs had sales of $536 million in second quarter 2014 and profits of $110 million, the company said.

HYDERABAD, India — Indian drug maker Dr. Reddy's Labs had sales of $536 million in second-quarter 2014 and profits of $110 million, the company said.

Those figures represented sales growth of 17% and a 76% growth in profits over second quarter 2013. Seventy-nine percent of the company's sales came from generic drugs, including 50% from sales in North America; sales of generics grew by 32% over last year.

November 1, 2013

The Food and Drug Administration has released a new video that warns consumers against buying drugs from rogue-internet pharmacies, part of the ongoing effort by the agency to keep fake and contaminated drugs out of the U.S. supply chain.

NEW YORK — The Food and Drug Administration has released a new video that warns consumers against buying drugs from rogue-internet pharmacies, part of the ongoing effort by the agency to keep fake and contaminated drugs out of the U.S. supply chain.

October 30, 2013

Community pharmacy is an important healthcare partner in providing cost-saving solutions within the healthcare system.

ARLINGTON, Va. — Community pharmacy is an important healthcare partner in providing cost-saving solutions within the healthcare system by helping to improve medication adherence, administering vaccinations and increasing the use of generic drugs. That was a key message of a statement sent by the National Association of Chain Drug Stores to Budget Committee conferees of the U.S. House of Representatives and the U.S. Senate.

October 29, 2013

Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

October 25, 2013

In recognition of National Prescription Drug Take Back Day being held Oct. 26, CVS/pharmacy has launched the CVS/pharmacy Medication Disposal for Safer Communities Program.

WOONSOCKET, R.I. — In recognition of National Prescription Drug Take Back Day being held Oct. 26, CVS/pharmacy has launched the CVS/pharmacy Medication Disposal for Safer Communities Program.

The new program is designed to provide police departments across the country with an easy way to team up with CVS/pharmacy locations in their area to hold National Drug Take Back Day events or to help raise community awareness of local drug disposal programs managed by law enforcement.

October 24, 2013

With the expansion of Medicaid services in the Patient Protection and Affordable Care Act on the horizon, the National Association of Chain Drug Stores and National Community Pharmacists Association sent a letter to CMS urging the agency to take into consideration the true cost of dispensing prescription medications to Medicaid patients.

ARLINGTON, Va. — With the expansion of Medicaid services in the Patient Protection and Affordable Care Act on the horizon, the National Association of Chain Drug Stores and National Community Pharmacists Association sent a letter to CMS urging the agency to take into consideration the true cost of dispensing prescription medications to Medicaid patients. 

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 22, 2013

The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

The FDA approved a generic version of Mission Pharmacal's Tindamax (tinidazole) made by Unique Pharmaceuticals. The drug is a tablet in the 250-mg and 500-mg strengths.

Tindamax is used to treat bacterial vaginosis, trichomoniasis and giardiasis. The drug has annual sales of about $16.2 million, according to IMS Health.

 

October 22, 2013

The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

SILVER SPRING, Md. — The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

October 22, 2013

Keeping counterfeit and diverted drugs out of the U.S. drug supply chain will require closing vulnerable regulatory gaps that risk letting them in, according to a new report by the National Association of Boards of Pharmacy.

NEW YORK — Keeping counterfeit and diverted drugs out of the U.S. drug supply chain will require closing vulnerable regulatory gaps that risk letting them in, according to a new report by the National Association of Boards of Pharmacy.

October 22, 2013

The state Senate of Pennsylvania will vote on a bill to curb misuse of prescription drugs, according to published reports.

NEW YORK — The state Senate of Pennsylvania will vote on a bill to curb misuse of prescription drugs, according to published reports.

The Beaver County, Pa., Times reported that Pennsylvania House Bill 1694 cleared the lower house of the state legislature in a 191-7 vote. The bill is designed to stop doctor-shopping and pill mills by creating an electronic prescription drug database to track drugs dispensed by doctors and veterinarians. Doctors and pharmacists can then use it to verify patients' medication histories.

October 21, 2013

The Food and Drug Administration is offering more than $14 million in grants for the development of products for patients with rare diseases, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration is offering more than $14 million in grants for the development of products for patients with rare diseases, the agency said Monday.

October 17, 2013

As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

October 17, 2013

Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.

CINCINNATI — Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.

The company, which focuses on authorized generic drugs, announced the deal for lanthanum carbonate chewable tablets in the 500-mg, 750-mg and 1,000-mg strengths. The drug is a version of Shire's Fosrenol. Authorized generics are branded drugs marketed under their generic names at a discounted price, usually through a third-party company under contract with the branded drug's manufacturer.

October 16, 2013

Medicare beneficiaries' use of medications — both effective and risky — varies widely across different regions of the United States, according to a new report.

LEBANON, N.H. — Medicare beneficiaries' use of medications — both effective and risky — varies widely across different regions of the United States, according to a new report.