Lupin gets FDA nod for 2 generics
Lupin has received the Food and Drug Administration’s approval for cinacalcet tablets, in dosage in strengths of 30 mg, 60 mg, and 90 mg.
Lupin’s product is the generic of Amgen’s Sensipar tablets, 30 mg, 60 mg, and 90 mg.
It is indicated in the treatment of secondary hyperparathyroidism, or HPT in adult patients with chronic kidney disease on dialysis; hypercalcemia in adult patients with parathyroid carcinoma; and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
Cinacalcet tablets, 30 mg, 60 mg, and 90 mg, had a market value of approximately $1.5 billion, according to IQVIA March 2019 data.
Lupin also received the FDA’s blessing for phenylephrine and ketorolac intraocular solution, 1%/0.3%.
The product is the generic of Omeros’s Omidria intraocular solution, 1%/0.3%.
It is indicated for maintaining pupil size by preventing intraoperative miosis, and for reducing postoperative ocular pain.The product is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.
Phenylephrine and ketorolac intraocular solution, 1%/0.3%, had a market value of about $42.8 million in according to March 2019 IQVIA data.
No comments found