Lupin launches Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in USA

The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling

Unichem’s US arm recalls Buspirone tablets after stability test OOS result

No adverse events reported; recall involves 5 mg 500-count bottles in the US market

Lupin wins USFDA nod for generic Dapagliflozin tablets

Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market

Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets

Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder

Glenmark Pharmaceuticals USA launches authorized generic of Savella tablets

Glenmark's Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg is the authorized generic to Savella Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg

Zydus receives final approvals from USFDA for Ivermectin Tablets USP

Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily indicated for treating parasitic worm infections in humans

Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets

The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder

Eugia Pharma receives USFDA Approval for Everolimus tablets

Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg

Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension

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