Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults

Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis

Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets

This product will be manufactured at Lupin’s Pithampur facility in India

Alembic announces USFDA tentative approval for Bosutinib Tablets, 100 mg and 500 mg

Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for recurrent endometrial cancer

Imfinzi also recommended for patients with mismatch repair deficient disease

Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg

Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients

Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC

Second FDA approval for KRAZATI - reinforcing its potential across tumor types

Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients