A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Hetero can launch a generic version of Forest Laboratories’ hypertension drug Bystolic three months prior to the expiration of Forest’s exclusivity on Dec. 17, 2021, or on the date it receives final ANDA approval from the agency, whichever is later, under the terms of a proposed settlement. Hetero may be able to offer its generic earlier in certain circumstances, Forest added. Generic Line