Drug Approval | December 22, 2025
Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Additional investments planned to expand the site’s capacity and capabilities to support growing manufacturing programs
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
SGX945 delivered beneficial effects in 7 of 8 patients suffering from painful oral ulcers
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
This marks the first partnership between Pfizer and Cipla in India
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy
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