12:00 AM
Jul 01, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Restasis cyclosporine regulatory update

FDA issued draft guidance for developing generic versions of Allergan's Restasis 0.05% cyclosporine ophthalmic emulsion that could lead to earlier than expected generic competition for the product. The agency recommended companies seeking an ANDA for the product conduct an in vitro study to determine the bioavailability or bioequivalence. The agency requested an in vivo bioequivalence...

Read the full 255 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Week In Review

Article Purchase

$35 USD
More Info >