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Par Pharmaceutical starts shipping generic version of Exforge

Par Pharmaceutical starts shipping generic version of Exforge

Par Pharmaceutical Companies, Inc. today announced that it has begun shipping all four strengths of amlodipine and valsartan tablets, the generic version of Novartis' Exforge. Par received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for amlodipine and valsartan and was granted 180 days of marketing exclusivity. [More]
FDA accepts Symplmed's Prestalia NDA for hypertension treatment

FDA accepts Symplmed's Prestalia NDA for hypertension treatment

Symplmed announced today that the U.S. Food and Drug Administration has accepted for review its New Drug Application (NDA) for investigational drug Prestalia, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the U.S. Symplmed filed the application under section 505(b)(2) consistent with FDA's guidance. [More]
Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc. [More]
Dr. Reddy's Laboratories launches Amlodipine Besylate and Atorvastatin Calcium Tablets

Dr. Reddy's Laboratories launches Amlodipine Besylate and Atorvastatin Calcium Tablets

Dr. Reddy's Laboratories announced today that it has launched Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10mg, 2.5/20mg, 2.5/40mg, 5/10mg, 5/20mg, 5/40mg, 5/80mg, 10/10mg, 10/20mg, 10/40mg and 10/80 mg a therapeutic equivalent generic version of CADUET (amlodipine Besylate and atorvastatin calcium) tablets, in the US market on March 26, 2014, following the approval by the United States Food & Drug Administration. [More]
FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. [More]
Calcium-channel blocker and antibiotic intake linked with small but greater risk of kidney injury

Calcium-channel blocker and antibiotic intake linked with small but greater risk of kidney injury

Among older adults taking a calcium-channel blocker, simultaneous use of the antibiotic clarithromycin, compared with azithromycin, was associated with a small but statistically significant greater 30-day risk of hospitalization with acute kidney injury, according to a study published by JAMA. The study is being published early online to coincide with its presentation at the American Society of Nephrology's Kidney Week 2013. [More]
Study assesses relationship between BMI and CV events in hypertensive patients with diabetes

Study assesses relationship between BMI and CV events in hypertensive patients with diabetes

Low BMI is a risk factor for CVD in hypertensive patients with diabetes, according to research presented at the ESC Congress today by Dr Takanori Nagahiro from Japan. The findings provide evidence for an obesity paradox in hypertensive patients with glucose intolerance. [More]
Diuretic-based antihypertensive therapy touted for obese

Diuretic-based antihypertensive therapy touted for obese

Diuretic-based antihypertensive regimens may be preferable to calcium channel blocker-based therapy in patients who are obese, suggest researchers writing in The Lancet. [More]
BMI may influence which blood pressure treatments work best

BMI may influence which blood pressure treatments work best

According to new research published Online First in The Lancet, body mass index (BMI) may influence which blood pressure medications work best at reducing the major complications of high blood pressure (strokes, heart attacks, and death). [More]
Latest polypill trial yields largest improvements yet

Latest polypill trial yields largest improvements yet

The results of the first trial to administer the polypill on the basis of age alone has shown the largest reductions in blood pressure and cholesterol level of any polypill trial to date, researchers report. [More]

No added benefit of aliskiren-amlodipine fixed drug combination for hypertension

The fixed drug combination of aliskiren and amlodipine (trade name: Rasilamlo-) was approved in April 2011 for the treatment of people with hypertension in whom aliskiren or amlodipine alone has an insufficient effect. [More]
Weight gain or loss may also depend on medicines taken

Weight gain or loss may also depend on medicines taken

Weight gain or loss may not always be caused by what you eat or how much you exercise. For some, it's the medicines you're taking. [More]

Ranbaxy signs consent decree with U.S. FDA

Ranbaxy Laboratories Ltd. today announced that it has signed a consent decree with the U.S. Food and Drug Administration. [More]
Ranbaxy introduces Atorvastatin-Amlodipine besylate tablets in the U.S.

Ranbaxy introduces Atorvastatin-Amlodipine besylate tablets in the U.S.

Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Ltd., has launched an authorized generic version of Caduet in the U.S. market, as part of an agreement with Pfizer Inc. [More]
FDA EMDAC votes to recommend approval of Merck's VYTORIN for pre-dialysis CKD

FDA EMDAC votes to recommend approval of Merck's VYTORIN for pre-dialysis CKD

Merck, known as MSD outside the United States and Canada, announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck's VYTORIN (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease. [More]
Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC(sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA (sitagliptin), with the cholesterol-lowering medication ZOCOR. [More]
Par Pharmaceutical reports second quarter total revenues of $224.2 million

Par Pharmaceutical reports second quarter total revenues of $224.2 million

Par Pharmaceutical Companies, Inc. today reported results for the second quarter ended June 30, 2011. [More]
Merck announces changes to high-dose simvastatin prescribing information in the U.S.

Merck announces changes to high-dose simvastatin prescribing information in the U.S.

Merck, known as MSD outside the United States and Canada, today announced changes to the prescribing information in the United States for the highest dose of simvastatin, 80 mg, and the use of simvastatin with certain other medicines. [More]
Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults. [More]
Mylan enters settlement agreement with Pfizer for Caduet Tablets litigation

Mylan enters settlement agreement with Pfizer for Caduet Tablets litigation

Mylan Inc. today announced that it has entered into a settlement agreement with Pfizer Inc. resolving litigation related to Caduet® Tablets, 2.5 mg/10, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg, known generically as Amlodipine Besylate/Atorvastatin Calcium Tablets. [More]