Content about Generics

March 5, 2014

In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for health of the Department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.

WASHINGTON — In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for Health of the department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.  

March 5, 2014

Dr. Reddy's Labs announced the launch of moxifloxacin hydrochloride tablets — the generic version of Avelox tablets — in 400-mg form.

HYDERABAD, India — Dr. Reddy's Labs announced the launch of moxifloxacin hydrochloride tablets, the generic version of Avelox tablets, in 400-mg form. The drug is available in bottle counts of 30.

Avelox tablets had U.S. sales of approximately $195 million for the 12 months ending in December 2013, according to IMS Health.

 

March 4, 2014

Teva Pharmaceutical Industries announced that it received approval for generic Evista (raloxifene) tablets, 60-mg, in the United States.

JERUSALEM — Teva Pharmaceutical Industries on Tuesday announced that it received approval for generic Evista (raloxifene) tablets, 60-mg, in the United States. The company was the first to file, which means the product is eligible for 180 days of marketing exclusivity. Teva will begin shipping the drug within the next 30 days.

Evista 60-mg tablets, marketed by Eli Lilly and Co., had annual sales in the United States of approximately $824 million as of December 2013, according to IMS data. The drug is used to prevent and treat osteoporosis in postmenopausal women.

March 3, 2014

The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

WASHINGTON — The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

March 3, 2014

"The problem [of counterfeit medicines] is so big, disperse and complex that it requires a sweeping coordinated global response," wrote Scott LaGanga, executive director of the Partnership for Safe Medicines and SVP public affairs and advocacy for PhRMA in a blog published by The Hill on Saturday.

WASHINGTON — "The problem [of counterfeit medicines] is so big, disperse and complex that it requires a sweeping coordinated global response," wrote Scott LaGanga, executive director of the Partnership for Safe Medicines and SVP public affairs and advocacy for PhRMA in a blog published by The Hill on Saturday.

February 28, 2014

Lupin announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150-mg, a generic version of Pharmacia and Upjohn Company's Mycobutin capsules.

MUMBAI and BALTIMORE — Lupin on Wednesday announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150 mg — a generic version of Pharmacia and Upjohn Company's Mycobutin capsules. The company's U.S. subsidiary will begin marketing the product soon.

The drug is used for the prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection. Mycobutin capsules had annual sales of $18.6 million in the United States, according to IMS MAT.

 

February 26, 2014

Dr. Reddy's Labs announced that it has launched Sumatriptan Injection USP, Autoinjector System 6-mg/0.5-mL, a generic version of Imitrex STATdose Pen (sumatriptan succinate) 6-mg/0.5-mL.

HYDERABAD, India — Dr. Reddy's Labs announced that it has launched Sumatriptan Injection USP, Autoinjector System 6-mg/0.5-mL, a generic version of Imitrex STATdose Pen (sumatriptan succinate) 6-mg/0.5-mL. The drug is available in a carton containing 2 single-dose prefilled syringes.

Sumatriptan is used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches, according to the company.

February 26, 2014

The annual ritual of visiting a doctor's office or health clinic to receive a flu shot may soon be outdated, thanks to the findings of a new study published in the journal Vaccine.

ATLANTA — The annual ritual of visiting a doctor's office or health clinic to receive a flu shot may soon be outdated, thanks to the findings of a new study published in the journal Vaccine.

February 26, 2014

Medication to treat high blood pressure in older patients appears to be associated with an increased risk for serious injury from falling, such as a hip fracture or head injury, especially in older patients who have been injured in previous falls, the JAMA Network Journals reported Monday.

CHICAGO — Medication to treat high blood pressure in older patients appears to be associated with an increased risk for serious injury from falling such as a hip fracture or head injury, especially in older patients who have been injured in previous falls, the JAMA Network Journals reported Monday. 

Most people older than 70 years have high blood pressure, and blood pressure control is key to reducing risk for myocardial infarction and stroke. Previous research has suggested that blood pressure medications may increase risk of falls and fall injuries.

February 26, 2014

A new national survey released Wednesday found that the majority of moms who have experienced head lice in their household as an adult (81%) used an OTC treatment the last time they had an infestation.

SWIFTWATER, Pa. — A new national survey released Wednesday found that the majority of moms who have experienced head lice in their household as an adult (81%) used an OTC treatment the last time they had an infestation. Less than a third of moms (27%) chose a prescription option.

February 25, 2014

The Drug Enforcement Administration's Atlanta Field Division last week announced the launch of an anonymous statewide prescription drug texting tip line available to the public.

ATLANTA — The Drug Enforcement Administration's Atlanta Field Division last week announced the launch of an anonymous statewide prescription drug texting tip line available to the public. 

February 25, 2014

As part of the National Governors Association’s ongoing effort to help states reduce prescription drug abuse, findings from the Prescription Drug Abuse Reduction Policy Academy were the focus of the Health and Human Services Committee session at NGA’s 2014 Winter Meeting, the association announced Sunday.

WASHINGTON — As part of the National Governors Association’s ongoing effort to help states reduce prescription drug abuse, findings from the Prescription Drug Abuse Reduction Policy Academy were the focus of the Health and Human Services Committee session at NGA’s 2014 Winter Meeting, the association announced Sunday. 

February 25, 2014

SpartanNash on Tuesday announced the formation of a partnership to offer a comprehensive mobile and web pharmacy solution to SpartanNash customers.

GRAND RAPIDS, Mich. — SpartanNash on Tuesday announced the formation of a partnership to offer a comprehensive mobile and web pharmacy solution to SpartanNash customers. The mobile solution, powered by mscripts, will enable SpartanNash customers to refill prescriptions, receive pickup and dosage reminders, and manage accounts for their family members. 

SpartanNash operates 88 pharmacies in six states throughout the upper Midwest.

February 24, 2014

It appears this year's flu season will officially wind down toward the beginning of March.

ATLANTA — It appears this year's flu season will officially wind down toward the beginning of March. The Centers for Disease Control and Prevention on Friday reported a decline in influenza activity, though nationwide it's still above the national baseline. 

No states reported high influenza like illness activity, the CDC noted, and seven states experienced moderate ILI activity (Arkansas, Delaware, Hawaii, Maryland, New Mexico, Texas and Virginia).

February 24, 2014

Concurrent opioid prescribing by multiple providers is common in Medicare patients and is associated with higher rates of hospital admission related to opioid use, according to a study published last week in BMJ.

LONDON — Concurrent opioid prescribing by multiple providers is common in Medicare patients and is associated with higher rates of hospital admission related to opioid use, according to a study published last week in BMJ

February 21, 2014

Only one-third of adults between the ages of 18 and 64 have gotten their flu shot this season, which is a contributing factor to why this year's flu activity has hit young adults particularly hard, according to Tom Frieden, director of the Centers for Disease Control and Prevention.

ATLANTA — Only one-third of adults between the ages of 18 and 64 have gotten their flu shot this season, which is a contributing factor to why this year's flu activity has hit young adults particularly hard, according to Tom Frieden, director of the Centers for Disease Control and Prevention. 

February 21, 2014

The Detroit Lions and Walgreens earlier this week teamed up to tackle the flu in Detroit Public Schools.

DETROIT — The Detroit Lions and Walgreens earlier this week teamed up to tackle the flu in Detroit Public Schools. On Feb. 25 Walgreens, the official health and wellness partner of the Detroit Lions, will give Detroit Lions Academy students flu immunizations.

Students who choose to get flu immunizations will have the opportunity to participate in a Playworks recess session that includes special guest Detroit Lions running back Joique Bell.

Families — parents and siblings — of students are also welcome to receive complimentary flu immunizations.

February 21, 2014

Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

ORLANDO, Fla. — Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl on Thursday highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

February 20, 2014

Kremers Urban Pharmaceuticals announced the launch of rabeprazole sodium delayed-release tablets, which are used to treat gastroesophageal reflux disease in adults and adolescents.

PRINCETON, N.J. — Kremers Urban Pharmaceuticals, a subsidiary of UCB, announced the launch of rabeprazole sodium delayed-release tablets. The drug is used to treat gastroesophageal reflux disease in adults and adolescents, according to the FDA.

The product is the bioequivalent to Aciphex from Eisai. Kremers Urban rabeprazole sodium delayed-release tablets are available in 20-mg strength in both 30- and 90-count bottles.

February 20, 2014

The Generic Pharmaceutical Association on Wednesday announced that Craig Wheeler, president and CEO, Momenta Pharmaceuticals, was elected as GPhA board chairman.

ORLANDO, Fla. — The Generic Pharmaceutical Association on Wednesday announced that Craig Wheeler, president and CEO, Momenta Pharmaceuticals, was elected as GPhA board chairman. Wheeler succeeds Tony Mauro, president, Mylan North America. 

February 20, 2014

Teva Pharmaceuticals announced the introduction of moxifloxacin hydrochloride tablets, the generic equivalent to Avelox tablets.

NORTH WALES, Pa. — Teva Pharmaceuticals announced the introduction of moxifloxacin hydrochloride tablets, the generic equivalent to Avelox tablets. The drug is available in 400-mg strength.

Moxifloxacin hydrochloride is used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria, the company said.

February 20, 2014

The Food and Drug Administration recently approved two "robotic pills," or pills that place an image camera or ingestible sensors into the gastrointestinal tract, according to a report published earlier this week by the Wall Street Journal.

NEW YORK — The Food and Drug Administration recently approved two "robotic pills," or pills that place an image camera or ingestible sensors into the gastrointestinal tract, according to a report published earlier this week by the Wall Street Journal

Other robotic pills still in development include one backed by Google — a pill that would replace injectable drugs, the report noted. 

February 19, 2014

Tricare for Life beneficiaries soon will receive letters guiding them to Tricare Pharmacy Home Delivery or a military pharmacy for some prescriptions as part of a congressionally mandated pilot program, officials of the military healthcare plan reported Tuesday.

FALLS CHURCH, Va. — Tricare for Life beneficiaries soon will receive letters guiding them to Tricare Pharmacy Home Delivery or a military pharmacy for some prescriptions as part of a congressionally mandated pilot program, officials of the military healthcare plan reported Tuesday.

Tricare for Life is secondary coverage for Tricare beneficiaries who have both Medicare Parts A and B in the United States and U.S. territories.

February 19, 2014

The Food and Drug Administration announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. 

In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

February 18, 2014

Actavis and Forest Labs. announced that they have entered into a definitive agreement under which Actavis will acquire Forest for a combination of cash and equity valued at approximately $25 billion, or $89.48 per Forest share ($26.04 in cash and 0.3306 Actavis shares for each share of Forest common stock).

DUBLIN — Actavis and Forest Labs. on Tuesday announced that they have entered into a definitive agreement under which Actavis will acquire Forest for a combination of cash and equity valued at approximately $25 billion, or $89.48 per Forest share ($26.04 in cash and 0.3306 Actavis shares for each share of Forest common stock). The per share consideration represents a premium of approximately 25% per share over Forest’s stock price, and a premium of approximately 31% over Forest’s 10-day volume weighted average stock price, as of the close of trading on Feb.