Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin...
Aurobindo Pharma Recalls Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty CapsulesNovember 24, 2014 3:04 pm | News | Comments
Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg...
The FDA has issued three additional policy documents to assist entities that compound sterile...
Federal health regulators have approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking such safeguards.
Half of all medicine available on the Afghan market has either been smuggled into the country or made under sub-standard conditions in neighboring Pakistan, according to a report released on Wednesday.
As a crucial second sign-up season gears up, the Obama administration said Sunday that HealthCare.gov is stable and working well, a far cry from last year's frozen computer screens and frustrated customers.
The U.S. Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. The drug has already been approved by the European Medicines Agency for use in the European Union and in Canada and Australia.
Janssen Pharmaceuticals has announced that the FDA approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.
Missouri House Speaker Tim Jones on Wednesday created a committee of lawmakers to review allegations that Attorney General Chris Koster has been influenced by lobbyist perks and campaign contributions.
Par Pharmaceutical Companieshas received approval for its New Drug Application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the U.S. Food and Drug Administration (FDA) pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
Veterans Affairs Secretary Robert McDonald announced the largest restructuring in the agency's history in the wake of a scandal over delayed care.
With sign-up season launching this weekend, the Obama administration sharply dialed down expectations Monday for the second year of the president's push to provide health insurance for all Americans.
The Supreme Court has agreed to hear a new challenge to President Barack Obama's health care law — a case that threatens subsidies that help millions of low- and middle-income people afford their health insurance premiums.
The nation's Heartland is ridding itself of the scourge of homemade methamphetamine, with lab seizures down by nearly half in many high-meth states. Any celebration is muted: Meth use remains high, but people are increasingly turning to cheaper, imported Mexican meth rather than making their own.
Ipsen Biopharmaceuticals announced that the FDA has approved a new device to deliver Somatuline® Depot® (lanreotide). The device has an enhanced, prefilled, low-volume syringe that supports full-dose delivery with no reconstitution requirements.
Ranbaxy Labs has received approval from the FDA to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively.
A reminder to pharma manufacturers, the Drug Supply Chain Security Act (DSCSA) deadlines are quickly approaching. Have you planned for the implementation of Transaction Documents for your packaged products and how to introduce them into your supply chain? Have you developed a strategy for implementing packaging serialized data and infrastructure?
AstraZeneca today announced that the FDA has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.
Pfizer announced that the FDA has granted accelerated approval of TRUMENBA ® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
The North Dakota Supreme Court on Tuesday upheld a state law that limits the use of drugs to perform abortions, a move abortion-rights supporters say will end the use of medications to perform the procedure.
In a letter Tuesday to key congressional committees, the National Association of Medicaid Directors said lawmakers should consider everything from outright price controls on manufacturers to federal help for states trying to pay for the new medications.
Researchers at Harvard found that two-thirds of dietary supplements that have previously been recalled still contain banned ingredients. Also, smoking may get in the way of recovering alcoholics.
HealthCare.gov's new EZ application for coverage can't be used by legal immigrants or naturalized U.S. citizens, prompting concern that many Hispanics and Asians will go right back into long enrollment queues this year.
Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. In supplements bought online, researchers detected hidden steroids, similar ingredients to Viagra and Prozac and a weight loss drug linked with heart attacks.
A North Carolina company is recalling nearly 12,000 boxes of pain relief tablets sold at Dollar Tree stores because some cartons contain a different medication that could cause allergic reactions.
The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.
Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.
Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.
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