The FDA has issued a revised draft guidance designed to allow for a more efficient approach to 505(q) petitions and allow the agency to focus more reviewer resources on scientific reviews.
Lannett marketed five new products in its recently completed fiscal 2019 first quarter, bringing the number of products launched since the beginning of the calendar year to 12.
Teva is launching the first generic Cialis, which had a market value of about $1.93 billion for the 12 months ended July 2018, according to IQVIA data.
The Association for Accessible Medicines is voicing strong opposition that the proposed U.S.-Mexico-Canada trade agreement will provide a windfall for brand-name drug manufacturers and raise prescription drug prices for patients.
Gilead has created a new subsidiary, Asegua Therapeutics, which will introduce authorized generic versions of its chronic Hep C medications, Epclusa and Harvoni in 2019.