Cipla bags USFDA nod for Lanreotide Injection
Mumbai: Cipla Limited along with its subsidiary Cipla USA, Inc., announced that it has received final approval for its Lanreotide Injection, from the United States Food and Drug Administration (USFDA).
The FDA approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. Lanreotide Injection is supplied in 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL singledose pre-filled syringes.
It is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).
Umang Vohra (MD and Global CEO, Cipla Limited) said, "We are pleased to receive the final approval for Lanreotide injection from the USFDA. Enabling access to high-quality treatments is core to our purpose of "Caring for Life".
Read also: Cipla to give nebulisers to primary health care centres in India
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