27 MARKET NEWS Drug progress through the US FDA FDA has given Upjohn marketing approval for 'Glynase', an improved formulation of its antidiabetic agent glibenclamide (glyburide, 'Micronase'). Study results have shown the bioavailability of the new product to be superior to that of'Micronase'. 'Glynase' will receive a minimum of 3 years exclusivity from generic Abbreviated New Drug Applications (ANDA). Chiron's interleukin 2 for advanced renal cancer now approved according to a report in the Wall Street Journal. It will be marketed as 'Proleukin'. This drug offers a long awaited treatment option for patients with aggressive renal cancer; results from 1 study have shown Chiron's interleukin 2 to reduce tumour size in 15% of patients with 4% of these having a complete remission. 'Proleukin' is the first agent to be licensed specifically for use in patients with advanced renal cancer. Unfortunately, most patients experience severe or life-threatening adverse effects. 'Proleukin' was launched in the UK earlier this year for the treatment of metastatic renal cell carcinoma. Lorex's 'Amhien' (zolpidem] recommended for approval. Lorex is a joint venture company between Searle and Synthelabo. Approval of this agent has been pending since 1989. Zolpidem, a nonbenzodiazepine hypnotic, will be marketed as 'Ambien' by Searle in North America; it was first launched in Europe by Synthelabo as 'Stilnox' and 'Stilnoct.' Zolpidem is claimed to have fewer adverse effects and a more specific mode of action than benzodiazepines. Advisory committee recommends Boehringer- Mann'heim's 'Presaril' (torsemide] for approval. This diuretic has been recommended for use in hypertension, oedema associated with congestive heart failure and cirrhosis of the liver. However, it is not recommended for use in patients with renal disease and oedema. The committee has urged Boehringer Mannheim to conduct further studies to evaluate the safety and efficacy of 'Presaril' at higher doses. ISSN 0156-2703/92/0516-OO27/51.00/0 c Adit Ltd INPHARMAe 16 May 1992

Drug progress through the US FDA

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27 MARKET NEWS

Drug progress through the US FDA FDA has given Upjohn marketing approval for

'Glynase', an improved formulation of its antidiabetic agent glibenclamide (glyburide, 'Micronase'). Study results have shown the bioavailability of the new product to be superior to that of'Micronase'.

'Glynase' will receive a minimum of 3 years exclusivity from generic Abbreviated New Drug Applications (ANDA).

Chiron's interleukin 2 for advanced renal cancer now approved according to a report in the Wall Street Journal. It will be marketed as 'Proleukin'.

This drug offers a long awaited treatment option for patients with aggressive renal cancer; results from 1 study have shown Chiron's interleukin 2 to reduce tumour size in 15% of patients with 4% of these having a complete remission.

'Proleukin' is the first agent to be licensed specifically for use in patients with advanced renal cancer. Unfortunately, most patients experience severe or life-threatening adverse effects.

'Proleukin' was launched in the UK earlier this year for the treatment of metastatic renal cell carcinoma.

Lorex's 'Amhien' (zolpidem] recommended for approval. Lorex is a joint venture company between Searle and Synthelabo. Approval of this agent has been pending since 1989. Zolpidem, a nonbenzodiazepine hypnotic, will be marketed as 'Ambien' by Searle in North America; it was first launched in Europe by Synthelabo as 'Stilnox' and 'Stilnoct.'

Zolpidem is claimed to have fewer adverse effects and a more specific mode of action than benzodiazepines.

Advisory committee recommends BoehringerMann'heim's 'Presaril' (torsemide] for approval. This diuretic has been recommended for use in hypertension, oedema associated with congestive heart failure and cirrhosis of the liver. However, it is not recommended for use in patients with renal disease and oedema.

The committee has urged Boehringer Mannheim to conduct further studies to evaluate the safety and efficacy of 'Presaril' at higher doses.

ISSN 0156-2703/92/0516-OO27/51.00/0 c Adit ~,"',""1111 Ltd INPHARMAe 16 May 1992