Lupin gets tentative US FDA approval for Dolutegravir Tablets for Oral Suspension
This product will be manufactured at Lupin’s Nagpur facility in India
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ANDA
Caplin Steriles gets USFDA nod for Cisatracurium Besylate injection
Cisatracurium Besylate Injection USP is a nondepolarising skeletal neuromuscular blocker, indicated as an adjunct to general…
Granules India gets ANDA approval for Gabapentin tablets
Gabapentin tablets are indicated for management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment…
Lupin gets tentative US FDA approval for Valbenazine capsules
Valbenazine is indicated for the treatment of tardive dyskinesia (uncontrollable movement of face, tongue, or other body parts)
NATCO announces ANDA filing for generic olaparib tablets in US
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer
Sun Pharma gets US FDA nod for generic lenalidomide capsules
The respective product approval is based on Revlimid Capsules, 5 mg, 10 mg, 15 mg, 25 mg and 2.5 mg, 20 mg as a reference product
Lupin gets USFDA approval for Glycopyrrolate Injection, USP
The product marks the first approval from Lupin’s new injectable facility in Nagpur, India
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
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