Takashi Shoda, the President and CEO of the Japanese pharmaceutical company Daiichi Sankyo - which bought a majority stake in Ranbaxy Laboratories last year - said that the company soon intends meeting officials of US Food and Drugs Administration to sort out regulatory problems at the Ranbaxy plant at Poanta Sahib in India.

Aurobindo Pharma announced that it has secured tentative approval from US Food and Drug Administration (USFDA) for Emtricitabine and Tenofovir Disoproxil Fumarate 200-mg/300-mg tablets under the President's Emergency Plan For AIDS Relief (PEPFAR).

Emtricitabine and Tenofovir Disoproxil Fumarate tabs, which come under the Anti-Retroviral (ARV) segment, are the generic version of Gilead Science Inc.'s HIV drug Truvada tablets.

Mylan Inc. said on Monday that its Indian arm Matrix Laboratories Limited has secured its first tentative approval from the U.S. Food and Drug Administration to market Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in two potencies 200 mg and 300 mg.

It should be noted that the tablets are the generic version of Gilead Science Inc.'s HIV drug Truvada Tablets.

The company said its version was granted tentative approval under the President's Emergency Plan for AIDS Relief.

Sun Pharmaceutical Industries announced that it has secured final approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) to market generic Topamax, topiramate tablets.

Topiramate, is a generic version of epilepsy drug Topamax, owned by Ortho-McNeil Pharmaceutical Inc, a division of Johnson & Johnson.

The tablets are available in four different potencies including 25 mg, 50 mg, 100 mg, and 200 mg.

The twelve-monthly sales of Topamax tabs stood at $2.5 billion in the US.

US health regulator Food and Drug Ad

India’s Aurobindo Pharma has notified that it has secured final approval from US Food and Drug Administration (USFDA) for marketing Topiramate tablets.

Aurbindo will market the pills in dosages of 25mg, 50mg, 100mg and 200mg.

The drug is prescribed for the treatment of epilepsy in both children and adults.

In many cases, the drug can also be used as an antidepressant, most of the time for depressive realism. In kids, it is also prescribed for treatment of Lennox-Gastaut syndrome, a disorder that causes seizures and developmental delay.