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 & 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.
Bangalore-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).
In 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.
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.