Pharmaceutical Sector

Strides Arcolab Receives Tentative USFDA Nod For HIV Drug

Strides Arcolab Receives Tentative USFDA Nod For HIV DrugBangalore-based Strides Arcolab, a global pharmaceutical company, has announced that it has got tentative approval from the U.S. Food and Drug Administration for a combination drug containing Lamivudine and Stavudine, which is used in the treatment of AIDS.

In an announcement, the company said that the sanction for lamivudine and stavudine in 150-milligram/30-mg dosages in tablet form, was expedited under the provisions of the President`s Emergency Plant for AIDS Relief (PEPFAR).

Suven Life to raise about $20 million for phase two trial of Alzheimer disease

Suven Life SciencesIn a latest development, Hyderabad-based drug developer Suven Life Sciences has informed that its molecule for Alzheimer's disease will soon enter phase two trials.

According to sources, the phase two trials will cost the company $20 million. The company is presently in the process of raising funds for the trials through a combination of debt, equity and strategic partner.

Last week, the company announced that more than half-a-dozen companies have shown interest in partnering the company for developing 'SUVN 502' molecule.

Daiichi Sankyo intends meeting US FDA to sort out Ranbaxy plant’s regulatory problems

Daiichi SankyoTakashi 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 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.

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