Alembic Pharma gets USFDA nod for Fulvestrant injection, 250 mg/5 mL per single-dose syringe
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer
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ANDA
Lupin gets US FDA approval for Brivaracetam Tablets
The product will be manufactured at Lupin’s facility in Nagpur, India
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 approves Ketorolac Tromethamine injection by Alembic Pharma
This is the second injectable product approval from the company's General Sterile Facility (F-3) which was inspected in August,…
US FDA approves Lupin’s Mirabegron extended-release tablets
The product will be manufactured at Lupin’s facility in Nagpur
Aleor Dermaceuticals gets USFDA approval for Diclofenac Sodium Topical Gel
It is indicated for the topical treatment of actinic keratoses
Alembic Pharmaceuticals receives US FDA tentative approval for Macitentan tablets, 10 mg
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Opsumit tablets, 10 mg, of…
Unichem Laboratories receives US FDA approval for divalproex sodium
These are the generic equivalent of Depakote ER (Divalproex Sodium) extended-release tablets 250 mg and 500 mg, of AbbVie Inc
Granules Pharmaceuticals receives ANDA approval for Amphetamine mixed salts from US FDA
The product is bioequivalent to the Reference Listed Drug (RLD) product Adderall of Teva Women’s Health Inc, and would be…