Aurobindo Pharma secures first nod for Finasteride APL Tablets

Aurobindo Pharma, one of the largest API manufacturers in Asia, on Wednesday received its first approval from Swissmedic, Government of Switzerland for the license of Finasteride APL Tablets 5mg.

The drug is generic equivalent of MERCK and CO., Inc’s Proscar Tablet.

Finasteride APL Tablet 5mg is used alone or in combination with another medication to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland). The drug is seen very effective in symptoms of BPH such as frequent and difficult urination. In addition, it also may decrease the chance of needing prostate surgery.

Further, the drug is also used to treat male pattern hair loss (a common condition in which men have gradual thinning of the hair on the scalp, leading to a receding hairline or balding on the top of the head.)

Earlier this month, Aurobindo Pharma has secured a tentative approval from the U. S. Food and Drug Administration to sell its emtricitabine and tenofovir disproxil fumarate combination drug in tablet form. The anti-HIV drug is the generic version of Gilead Sciences Inc’s branded drug Truvada.

On the same day, the company got another nod for its Topiramate tablets in 25mg, 50mg, 100mg and 200mg strengths from the US Food and Drug Administration (US FDA).

The drug is generic equivalent of Ortho McNeil Janssen Pharmaceuticals’ Topamax tablets and indicated for the treatment of epilepsy in both children and adults.

Common anti-seizure drugs may increase risk of cardiovascular problems

Washington, Mar 19 (ANI): Two of the most commonly prescribed anti-seizure medications may increase the risk of cardiovascular problems, such as high cholesterol levels and C-reactive protein, according to a study.

The discovery of this repercussion in the treatment of epilepsy may help doctors offer better care of patients with seizures by prescribing different anti-seizure medications that do not harm cardiovascular health.

Led by Dr. Scott Mintzer, assistant professor in the Department of Neurology at Jefferson Medical College of Thomas Jefferson University, the study focussed on two of the most widely prescribed anticonvulsants – phenytoin (Dilantin) and carbamazepine (Tegretol, Carbatrol).

The two drugs have potent effects on many enzymes in the body involved in different areas of metabolism.

For the study, the researchers recruited 34 epilepsy patients taking either one of the two drugs, and were being switched over to one of two newer anti-seizure drugs, which do not widely affect enzymes – lamotrigine (Lamictal) or levetiracetam (Keppra).

Their aim was to find out whether the change affected the patients’ cholesterol levels and other key markers of cardiovascular disease.

Significant declines in total cholesterol, “bad” cholesterol, triglycerides and C-reactive protein were seen in just six weeks after the patients’ drugs were switched.

That indicated that the older, commonly used drugs might substantially increase the risk of cardiovascular disease, said the researchers.

“The epilepsy patients in this study saw a rapid and clinically significant improvement in several markers related to cardiovascular disease, including a decrease in total cholesterol that averaged 26 points. This is almost certainly not due to some positive effect from the new drugs. It’s a consequence of being taken off the older ones, which were causing the cholesterol and other markers to be elevated in the first place,” said Mintzer.

He added: “While more investigation is needed, these results may help physicians better understand the risks of these drugs and choose the most appropriate treatment for their epilepsy patients, especially those who are already at risk for cardiovascular disease or have a family history of it.”

The study has been published in the online edition of Annals of Neurology. (ANI)