US FDA approves Acer Therapeutics’ genetic disorder drug
The approval letter, issued recently, said the drug, sodium phenylbutyrate, could be used as an adjunctive therapy to the standard…
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US FDA approval
US FDA approves Mirati’s lung cancer drug
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
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
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
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
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
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
Doxycyline capsule is a generic equivalent of Galderma Laboratories' Oracea capsules
US FDA gives tentative approval to Lupin for Drospirenone tablets
Drospirenone tablets had estimated annual sales of $141 million in the US