FDA Approves Conjupri (levamlodipine maleate) for the Treatment of Hypertension

 The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that Conjupri® (levoamlodipine maleate) tablets has received marketing approval from the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Based on our knowledge, this is the first New Drug Application (NDA) ever submitted to the FDA by Chinese pharmaceutical companies, and now granted full approval following a standard review by the FDA.

Levoamlodipine is the purified (S)-amlodipine, the pharmacologically active enantiomer in amlodipine (a racemic mixture of (R)- and (S)-amlodipine), for the treatment of hypertension. Amlodipine is a third-generation calcium channel blocker first developed and marketed by Pfizer as NORVASC® (amlodipine besylate) tablets in 2.5 mg, 5.0 mg, and 10.0 mg in 1992. The approved Conjupri® (levoamlodipine maleate) tablets come in 1.25 mg, 2.5 mg and 5.0 mg.

Levoamlodipine maleate tablets have been marketed by the Group as Xuanning ( 玄寧) in China since 2003. The clinical development of levoamlodipine maleate tablets in the U.S. was based on the safety and efficacy data demonstrated in China and data showing that levoamlodipine has less adverse events than amlodipine.

This NDA approval allows the Group to market Conjupri® in the U.S. and also paves the way for marketing in other parts of the world. As the first levoamlodipine approved by the FDA, Conjupri® is qualified to be the reference standard for drugs with the same active ingredient.

The NDA approval of levoamlodipine maleate tablets in the U.S. is a manifestation of the Group’s commitment to innovation and to bringing the best medicines to patients worldwide.

https://en.wikipedia.org/wiki/Levamlodipine

New action for ancient heart drug

New action for ancient heart drug

Since the 13th century, the herb and poisonous plant Foxglove has been used to cleanse wounds and its dried leaves were carefully brewed by Native Americans to treat leg swelling caused by heart problems. Digoxin (see structure), the active ingredient in digitalis, or the poisonous plant Foxglove, can enhance the body's own protective mechanism against high blood pressure and heart failure.

 

High blood pressure can be prevented by reducing salt intake, being active and keeping a healthy weight, but about 1 in 3 Americans has high blood pressure, also called hypertension, which can damage the body in many ways.  Most current treatments prevent excess hormone and stress signals that can lead to high blood pressure and heart failure.

But recent studies have found that the body has the ability to keep excess stimulation in check through production of a family of inhibitors called RGS proteins. Researchers looked for ways to "re-purpose" old drugs to tap into this protective mechanism which is lost among some individuals with high blood pressure and heart failure. 

Ref; http://www.uofmhealth.org/news/digoxin-0613

Bioactive Compounds (anthocyanins) in Berries Can Reduce High Blood Pressure

We have already seen the benefits of anthocyanins, and also how useful the blue berries are. Now the researchers from University of East Anglia (UEA) and Harvard University, have further substantiated the usefulness of blue berries. As per the claim by the researchers eating blueberries can guard against high blood pressure.

The new findings show that bioactive compounds in blueberries called anthocyanins offer protection against hypertension. Compared with those who do not eat blueberries, those eating at least one serving a week reduce their risk of developing the condition by 10 per cent.

Anthocyanins (see structure) belong to the bioactive family of compounds called flavonoids and are found in high amounts in blackcurrants, raspberries, aubergines, blood orange juice and blueberries. Other flavonoids are found in many fruits, vegetables, grains and herbs. The flavonoids present in tea, fruit juice, red wine and dark chocolate are already known to reduce the risk of cardiovascular disease.

During the study, 35,000 participants developed hypertension. Dietary information identified tea as the main contributor of flavonoids, with apples, orange juice, blueberries, red wine, and strawberries also providing important amounts. When the researchers looked at the relation between individual subclasses of flavonoids and hypertension, they found that participants consuming the highest amounts of anthocyanins (found mainly in blueberries and strawberries in this US-based population) were eight per cent less likely to be diagnosed with hypertension than those consuming the lowest amounts. The effect was even stronger in participants under 60.

The effect was stronger for blueberry rather than strawberry consumption. Compared to people who ate no blueberries, those eating at least one serving of blueberries per week were 10 per cent less likely to become hypertensive.

"Our findings are exciting and suggest that an achievable dietary intake of anthocyanins may contribute to the prevention of hypertension," said lead author Prof Aedin Cassidy of the Department of Nutrition at UEA's Medical School".......

Ref: http://www.uea.ac.uk/mac/comm/media/press/2011/January/berries .

Nicardipine Hydrochloride injection is back !

About Nicardipine :

We know that Nicardipine hydrochloride (Cardene) is a medication used to treat high blood pressure and angina. It belongs to the class of calcium channel blockers.

Nicardipine is a dihydropyridine calcium-channel blocking agent used for the treatment of vascular disorders such as chronic stable angina, hypertension, and Raynaud's phenomenon. It is available in oral and intravenous formulations. Its mechanism of action and clinical effects closely resemble those of nifedipine and the other dihydropyridines (amlodipine, felodipine), except that nicardipine is more selective for cerebral and coronary blood vessels. Furthermore, nicardipine does not intrinsically decrease myocardial contractility and may be useful in the management of congestive heart failure. Nicardipine also has a longer half-life than nifedipine. Nicardipine was approved by the FDA in December 1988. The patent for both Cardene and Cardene SR expired in October 1995.

Recently, Caraco Pharmaceutical Laboratories, Ltd. has launched Nicardipine Hydrochloride Injection immediately following Sun Pharma's final approval from the US Food and Drug Administration (FDA).

Nicardipine Hydrochloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. These Nicardipine Hydrochloride Injections are available as 25 mg/10ml single use ampuls containing 2.5 mg/ml of the drug....

Source : http://phx.corporate-ir.net/phoenix.zhtml?c=98920&p=irol-newsArticle_Print&ID=1356898&highlight=

Valturna gets FDA approval .....

FDA, has approved Valturna (valsartan & aliskiren respective structures above) tablets, the first and only medicine to target two key points within the renin system, also known as the renin angiotensin aldosteronesystem (RAAS), an important regulator of blood pressure. This is the first approval for Valturna, which is indicated for the treatment of Hypertension (high blood pressure) in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. This unique combination brings together the powerful blood pressure lowering effects of valsartan and aliskiren. Valturna combines in a single pill valsartan, the active ingredient in Diovan((R)), the number one selling branded Hypertension medicine worldwide, and aliskiren, the active ingredient in Tekturna((R)), the only approved direct renin inhibitor (DRI). Valturna offers significantly greater blood pressure reduction than either valsartan or aliskiren alone. Now for the first time, patients have a treatment option in one pill that targets two key points of the RAAS, which may be overactive in many hypertensive patients. The important fact about the combination is - by targeting two key points within the RAAS, Valturna helps blood vessels relax and widen so blood pressure is lowered. Research suggests that up to 85% of hypertensive patients may need multiple medications to help control their blood pressure, underscoring the need for effective combination treatments, hope this combined drugs will help the patients to a large extent. But those people with stroke, heart attack, heart failure, kidney failure or eye problems resulting from hypertension will have to wait for some more time....

Ref : http://www.novartis.com/newsroom/media-releases/en/2009/1342100.shtml