Corporate News     09-Jul-24
Alembic receives USFDA approval for Bromfenac Ophthalmic Solution
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution, 0.07%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Incorporated (Bausch).

Bromfenac Ophthalmic Solution 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Bromfenac Ophthalmic Solution, 0.07% has an estimated market size of US$ 168 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 207 ANDA approvals (180 final approvals and 27 tentative approvals) from USFDA.

Previous News
  Intellect Design Arena Ltd leads losers in 'A' group
 ( Hot Pursuit - 10-May-24   15:00 )
  Alembic Pharma gets USFDA nod for stroke and blood clots drug
 ( Hot Pursuit - 18-Jun-24   14:27 )
  Alembic Pharma's oncology formulation facility undergoes USFDA audit
 ( Corporate News - 09-Mar-24   12:26 )
  Alembic Pharmaceuticals Ltd leads losers in 'A' group
 ( Hot Pursuit - 09-Aug-24   15:00 )
  Alembic Pharmaceuticals to conduct board meeting
 ( Corporate News - 26-Jul-24   09:29 )
  Alembic Pharmaceuticals consolidated net profit rises 48.01% in the December 2023 quarter
 ( Results - Announcements 05-Feb-24   14:52 )
  Alembic Pharma gets USFDA nod for Docetaxel injection
 ( Hot Pursuit - 01-Mar-23   11:59 )
  Alembic Pharmaceuticals to convene board meeting
 ( Corporate News - 18-Jan-23   10:51 )
  Volumes jump at Alembic Pharmaceuticals Ltd counter
 ( Hot Pursuit - 21-Feb-23   11:00 )
  Alembic Pharm gets US FDA approvals for five products in Q1 FY24
 ( Hot Pursuit - 03-Jul-23   09:54 )
  Alembic Pharmaceuticals receives USFDA approval (final & tentative) for 11 products
 ( Corporate News - 03-Jul-24   15:42 )
Other Stories
  Optiemus showcases its high endurance Vajra 65 and Vajra 100 quadcopter drones
  07-Oct-24   20:12
  Bharat Electronics wins new orders of Rs 500 cr
  07-Oct-24   20:09
  Jaguar Land Rover records 3% drop in Q2 retail sales
  07-Oct-24   19:42
  Piccadily Agro launches limited edition Indri's 'City Series' for Bengaluru Duty Free
  07-Oct-24   19:39
  MOIL records best September production & sales
  07-Oct-24   19:37
  Electrosteel Castings acquires Singardo International
  07-Oct-24   19:30
  Avenue Supermarts to acquire 26% stake in FP Ampere Energy
  07-Oct-24   19:28
  Force Motors acquires 12.21% stake in TP Surya (SPV for solar power projects)
  07-Oct-24   19:09
  CreditAccess Grameen allots 3,614 equity shares under ESOP
  07-Oct-24   19:07
  Havells India allots 22,662 equity shares under ESPS
  07-Oct-24   19:04
Back Top