Barr Laboratories has received final approval from FDA for ANDA to manufacture and market a generic version of Yasmin, an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.
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Roxane Laboratories announced the approval of its ANDA for Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg by FDA. The product is available in Bottles of 100 and is available for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories' Ropinirole Hydrochloride Tablets are AB rated to REQUIP (ropinirole hydrochloride) Tablets. Annual sales of Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg are approximately $499 Million(1).
For consumers who pay for all or most of their prescription drugs out of pocket, a new price study by Consumer Reports finds that it pays to shop around. Not only do prices vary from store to store for the same drug, but the fluctuations can be dramatic -- sometimes more than $100 for the same prescription -- even with the same chain, depending on whether consumers are filling their prescriptions in, say, Omaha, Nebraska, or Billings, Montana.
Novartis' clinical trial of meningitis vaccine Menveo showed the drug successfully boosts immune system possibly becoming a treatment in the future.
In 2007, patients in US left their doctors office with at least one prescription on 550 million separate occasions. Millions then made two trips to the pharmacy following their doctor's visit, one to drop off the prescription and another to pick it up.
Now with a new technology called "e-prescriptions," a patient can choose to have their prescription electronically transmitted to the pharmacy before they ever leave their doctor's office.
Two days ago Merck received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.
In order to improve the safety of imported prescription drugs and medications FDA asks the Congress for more authority and resources.
The fact that the heart failure treatment drug Digitek (Digoxin) may contain twice the approved level of active ingredient than is appropriate has prompted Digitek recall by Actavis Totowa.
Actavis Totowa is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use.
FDA has granted final approval for Breckenridge Pharmaceutical's ANDA to market its generic version of Novo Nordisk's Activella Tablets (Estradiol/Norethindrone Acetate 1.0mg / 0.5mg) Tablets.
Heritage Pharmaceuticals announced the immediate availability of Nimodipine Soft Gelatin Capsules in 30 mg strength. Heritage's development and manufacturing partner, Banner Pharmacaps Inc., received final approval of its Abbreviated New Drug Application (ANDA) for an AB Rated equivalent of Nimotop on January 17, 2008.
Nimodipine Soft Gel Capsules are the generic equivalent of Nimotop Capsules marketed by Bayer. Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage.
Litigation involving drug maker Merck has revealed new information about safety concerns associated with the drug Vioxx, pulled from the market in 2004. Legal documents recently made public show the company found an increased risk in mortality rates during clinical trials to treat patients with Alzheimer's disease but the dangers were never made clear to the public.
One-third of America's 225 million prescription-takers now report experiencing a prescription error or knowing someone who has.
Enanta Pharmaceuticals presents breakthrough research program to evaluate a new macrolide-related drug class, Bicyclolides, in the treatment of methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, and other gram-positive infection pathogens.
Nektar Therapeutics has ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group. All new incidences of lung cancer were in patients that are former smokers.
Take a look in your medicine cabinet -- do you spot prescription pain medication?
HealthLeaders-InterStudy reports that the high cost of specialty drugs is forcing Pennsylvania insurers to get creative in finding ways to control those costs. Specialty drugs -- medications developed through a biological process that are generally injected or infused -- are rising at a rate twice to three times the pace of traditional medications.
New cost-sharing policies may prevent some older adults diagnosed with depression from filling new antidepressant prescriptions.
At least 33 US states have implemented laws to allow or study programs that redistribute unused prescription medications to uninsured or low-income individuals.
European Commission has approved Eli Lilly and Company's new indication for FORSTEO for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture.
FDA approved Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis in infants and children.