US FDA approves Acer Therapeutics’ genetic disorder drug Reuters Dec 26, 2022 The approval letter, issued recently, said the drug, sodium phenylbutyrate, could be used as an adjunctive therapy to the standard…
US FDA approves Mirati’s lung cancer drug Reutetrs Dec 15, 2022 Mirati was seeking approval for the drug for treating patients with advanced lung cancer who have stopped responding to other…
US FDA gives final approval to Alembic Pharma’s Desonide cream EP News Bureau Dec 9, 2022 The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Desonide Cream, 0.05%, of Padagis
US FDA gives final approval to Alembic Pharma’s Diclofenac Sodium Topical Solution EP News Bureau Dec 1, 2022 Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knees
US FDA approves JB Pharma’s generic Venlafaxine extended-release tablets EP News Bureau Nov 30, 2022 The product is based on Osmotic Controlled Release Oral Delivery System (OROS) technology, an advanced and precision controlled…
US FDA gives final approval to Alembic Pharma’s Nifedipine extended-release tablets EP News Bureau Nov 21, 2022 The tablets are indicated for the management of vasospastic angina, chronic stable angina (classical effort-associated angina) and…
US FDA gives final approval to Alembic Pharma’s Cyclophosphamide capsules EP News Bureau Nov 14, 2022 Cyclophosphamide capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic…
Lupin gets FDA nod to market generic antibiotic medicine in US Press Trust of India Nov 10, 2022 Doxycyline capsule is a generic equivalent of Galderma Laboratories' Oracea capsules
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,…