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cinacalcet

Generic: CINACALCET HYDROCHLORIDE·Brand: CINACALCET HYDROCHLORIDE, SENSIPAR, Sensipar

cinacalcet: developed by 1 company · 1 FDA decision.

cinacalcet evidence translation

What we can confirm

What it means

Source-backed records connect cinacalcet to RDY; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could cinacalcet → RDY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Development Pipeline (2)
CompanyPhase
DR REDDYS LABORATORIES LTD (RDY)Approved
DR REDDYS LABORATORIES LTD (RDY)Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Cinacalcet tablet is a positive modulator of the calcium sensing receptor indicated for: • Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use : Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis • Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) • Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be ind(RDY)FDA ↗
ANDA208368UNKNOWNStandardOralTablet

Frequently asked questions

Who is developing cinacalcet?

cinacalcet is being developed by DR REDDYS LABORATORIES LTD.

What is cinacalcet's latest FDA decision?

The most recent tracked FDA decision for cinacalcet is Approval for 1 INDICATIONS AND USAGE Cinacalcet tablet is a positive modulator of the calcium sensing receptor indicated for: • Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use : Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis • Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) • Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be ind, dated September 18, 2020.