Tag: USFDA
Public hospitals keeping Indian medical devices out of bounds for patients?
The association of domestic MedTech players, AIMED has issued a list of tenders recently floated by over 20 public institutions including state medical corporations, and hospitals which have stipulated discriminatory restrictive clauses...............
Pharma recalls posing a serious threat?
There have been several other instances wherein drugs are being recalled either on a firm's own initiative or the request by Food and Drug Administration (FDA)............
Panacea Biotec announces joint collaboration with Biopharma Inc
Under the collaboration, Panacea Biotec will be responsible for manufacturing and supply of the new drug entities of Biopharma Inc which again will be a distributor of these ANDAs in the United States and its territories..........
Biocon & Mylan’s proposed biosimilar ‘Trastuzumab’ gets USFDA nod
The US-FDA Oncologic Drugs Advisory Committee has unanimously recommended approval of Mylan and Biocon’s proposed cancer targeting biosimilar, Trastuzumab.............
Dr Reddy’s Laboratories gets USFDA’s EIR to API plant in Telangana
The US Food and Drug Administration has given an 'establishment inspection report' to the company after inspection of Dr Reddy Laboratories active pharmaceutical ingredients (API) unit at Miryalaguda in Telangana.........
USFDA to lift import alert on Sun Pharma’s Mohali facility
Regulator will permit the supply of products from Mohali facility inherited by Sun Pharma from Ranbaxy, to the US market .........
USFDA accepts Mylan & Biocon’s proposed biosimilar Pegfilgrastim for review
The development marks the second successful biologics license application (BLA) for filing of the partnership in the United States of America...
Strides Shasun receives USFDA tentative approval for Fingolimod capsules
On receiving full approval, the product will be manufactured at the company’s oral dosage facility at Bangalore and marketed by its subsidiary in USA, Strides Pharma Inc....
Laser-assisted cataract treatment to benefit 74% of 60 year old Indians
US Food and Drug Administration (US-FDA) approved LenSx Laser system is the market leader in the Femto-laser segment which has performed more cataract surgeries worldwide than any other laser system....
US-FDA accepts Mylan & Biocon’s joint application on biosimilar Trastuzumab
While the Biologics License Application (BLA) for MYL-1401O has been accepted by the United States FDA, if approved, it has the potential to be the first biosimilar Trastuzumab in the US....