US FDA gives tentative approval to Lupin for Drospirenone tablets EP News Bureau Nov 7, 2022 Drospirenone tablets had estimated annual sales of $141 million in the US
US FDA approves Ketorolac Tromethamine injection by Alembic Pharma EP News Bureau Nov 3, 2022 This is the second injectable product approval from the company's General Sterile Facility (F-3) which was inspected in August,…
US FDA gives final approval to Glenmark Pharma’s Sodium Phenylbutyrate tablets EP News Bureau Nov 3, 2022 The tablets will be distributed in the US by Glenmark Pharma Inc., USA
US FDA gives final approval for Mesalamine extended-release capsules EP News Bureau Nov 2, 2022 Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
US FDA gives final approval to Zydus’s Acetaminophen injection EP News Bureau Oct 31, 2022 Acetaminophen injection is indicated to relieve mild-to-moderate pain, and to reduce fever
US FDA gives final approval to Alembic Pharma’s Paclitaxel injection EP News Bureau Oct 28, 2022 This is the first product approval for oncology injection from the company's F-2 Facility (oncology injectable) which recently…
Johnson & Johnson’s blood cancer therapy gets US FDA approval Reuters Oct 27, 2022 J&J's teclistamab, branded as Tecvayli, is approved for treating adults with multiple myeloma that is hard to treat, or has…
US FDA grants final approval to Zydus’s Micafungin for injection EP News Bureau Oct 26, 2022 Micafungin for injection is indicated to treat variety of fungal infections
US FDA authorises Novavax’s COVID vaccine as booster for adults Reuters Oct 21, 2022 The regulator's decision is in addition to the earlier clearance for the vaccine as a primary two-shot regimen for those aged 12…
US FDA grants tentative approval to Zydus’s Amantadine extended-release capsules EP News Bureau Oct 10, 2022 The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ