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The approval was based on data obtained from the KODIAC clinical programme, which involved four studies, namely KODIAC-4, -5, -7 and -8. While KODIAC-4 and -5 were both

According to the US Environmental Protection Agency (EPA), the company has agreed to pay civil penalty of $172,900 to resolve the issue. The agreement dissolves the firm’s alleged

Amoxicillin for oral suspension USP 125mg/5mL and 250mg/5mL is the standard equivalent to the Teva Pharmaceutical Industries’ reference listed drug product (RLD), Amoxicillin for oral suspension. This drug

Endo president and chief executive officer Rajiv De Silva said: "Endo’s proposal would provide Auxilium shareholders a substantial premium and immediate cash value for their investment in Auxilium,

Under the terms of agreement, Pfizer will gain an exclusive, worldwide option to license and use MedGenesis’ glial cell line-derived neurotrophic factor (GDNF) protein and convection enhanced delivery

In a study in Japanese patients, omarigliptin provided comparable efficacy and tolerability to Merck’s once-daily DPP-4 inhibitor JANUVIA® (sitagliptin) 50 mg, which is the standard starting dose for

Significant pre-launch activities are well underway as PTC prepares for the commercial launch of Translarna™ (ataluren) in the European Union. In August of this year, Translarna received approval

According to IMS, for the 12 months ending July 2014, the US market for Ketorolac approximated $34 million. As with all products in Sagent’s portfolio, Ketorolac features Sagent’s

A statistically significant and clinically relevant response was seen in a prospectively-identified, substantial sub-group of patients with moderate to severe pain who had relatively intact sensory responses as