Theravance, Inc, said a US Food and Drug Administration (FDA) panel, anti-infective drugs advisory committee, will soon meet to review the company's new drug application for skin infection drug telavancin.

The FDA has recently sent a notice regarding the NDA review of telavancin, a novel, bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). Further details will be provided by Theravance upon receipt of additional information from FDA, the company said in a recent press statement.

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialisation of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction.

Also, Theravance and Astellas Pharma Inc. (Astellas) inked a collaboration agreement for the development and commercialisation of telavancin worldwide. Under the terms of the collaboration, Theravance will lead the development of and US regulatory process for telavancin for the treatment of cSSSI and hospital-acquired pneumonia (HAP), and will collaborate substantially with Astellas in marketing in the United States for the first three years. Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities.