Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets

Lupin launches Topiramate ER capsules in US

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals

Lupin launches Dasatinib tablets in US, eyes $930 million oncology market

Indoco Remedies bags USFDA nod for Lacosamide oral solution

The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa

Alembic announces USFDA tentative approval for Bosutinib tablets

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

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

Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity

The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,

Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension