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
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea
Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis
Dexlansoprazole delayed-release capsules are a proton pump inhibitor
Sumatriptan injection is indicated in adults for the acute treatment of migraine
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