Last Updated on October 14, 2024 by The Health Master
Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Cyanocobalamin Nasal Spray, 500 mcg/spray (One Spray per Device).
According to the company’s press statement, it is a generic equivalent of Nascobal Nasal Spray, 500 mcg/spray of Par Pharmaceutical, Inc.
This product will be manufactured at Lupin’s Somerset facility in the United States.
Cyanocobalamin is a form of vitamin B12 used to treat vitamin B12 deficiency.
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023).
USFDA approves drug for growth hormone deficiency in kids
USFDA approves this drug to treat hair loss
USFDA gives approval for Tiotropium dry powder inhaler
USFDA gives approval for generic acne-treating drug
USFDA gives final nod for Varenicline Tablets
USFDA gives approval for Levetiracetam Tablets
Govt has adopted a ‘Zero Tolerance’ policy on spurious medicines: HM
DTAB recommends amendment to Pack Size provisions for Tablets and Capsules
USFDA completes inspection of Granules India in two facilities
Hyderabad Pharma City: A Thriving Hub for Pharma Industry
DTAB: Examination of RMP requirement for sale of Cough Syrups
NPPA fixed Ceiling price of 2 scheduled formulations: June 2023
CDSCO orders transfer of 33 Deputy Drugs Controllers: List here
Explosion in Pharma Company: Andhra Pradesh
