Pharmaceutical Sector

Aurobindo Pharma Gets Tentative Nod From USFDA For HIV Infection Drug; Stock Up 9%

Aurobindo Pharma Gets Tentative Nod From USFDA For HIV Infection Drug; Stock Up 9%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’s Indian Arm Matrix Gets Tentative USFDA Nod For Truvada

Mylan’s Indian Arm Matrix Gets Tentative USFDA Nod For TruvadaMylan 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 Pharma Gets USFDA Nod To Market Generic Topamax Tabs; Stock Up 2.1%

Sun Pharma Gets USFDA Nod To Market Generic Topamax TabsSun 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 FDA approves Topamax tablets

US FDA approves Topamax tabletsUS health regulator Food and Drug Ad

Aurobindo Gets USFDA Nod For Topiramate Tablets

Aurobindo Gets USFDA Nod For Topiramate TabletsIndia’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.

Glaxo To Share More Than 800 Patents; Cuts Drug Costs To Aid Poor

Glaxo To Share More Than 800 Patents; Cuts Drug Costs To Aid PoorGlaxoSmithKline Plc (GSK.L) will share over 800 of its patents with researchers trying to make new medicines for tropical diseases, including malaria, and HIV/Aids.

The world's second-largest drug manufacturer also said that it will lessen the price of its drugs in poor nations from next week.

GlaxoSmithKline declared the moves on Tuesday during its annual corporate responsibility report, following a promise by Chief Executive Andrew Witty in an address at Harvard in February 2009 to do more to aid the developing world.

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