Zydus gets USFDA approval for estradiol and levonorgestrel transdermal system
The product has been designated as a Competitive Generic Therapy and is eligible for a 180-day exclusivity period, subject to…
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Browsing Tag
USFDA approval
Glenmark receives USFDA approval for Fluticasone Propionate Nasal Spray
Fluticasone Propionate Nasal Spray USP is bioequivalent and therapeutically equivalent to Flonase Nasal Spray
Lupin receives USFDA approval for Pitolisant Tablets
The approval covers Pitolisant Tablets 4.45 mg and 17.8 mg, bioequivalent to Wakix for the indications in the approved labelling
Zydus receives USFDA approval for generic Indocyanine Green for Injection
Dr Sharvil Patel says the approval expands Zydus’ portfolio of injectable and imaging products and supports its focus on…
Alembic Pharma gets USFDA nod for Methotrexate Injection USP, 50 mg/2 mL multi-dose vials and 1g/40…
Methotrexate Injection is a folate analog metabolic inhibitor indicated for neoplastic diseases
Alembic Pharmaceuticals receives USFDA approval for Lamotrigine Orally Disintegrating tablets
Company secures final approval for ANDA across four strengths; cumulative USFDA ANDA approvals reach 235
USFDA grants orphan drug designation to Zydus’ Desidustat for sickle cell disease
Designation covers oral HIF-PHI therapy for SCD
Alembic Pharmaceuticals receives USFDA approval for Loteprednol Etabonate and Tobramycin Ophthalmic…
Company secures final ANDA approval with eligibility for 180 days of CGT exclusivity
Zydus Lifesciences receives USFDA approval for Diroximel Fumarate delayed-release capsules
The approval covers the treatment of relapsing forms of multiple sclerosis in adults, with production to take place at Zydus…
Alembic Pharmaceuticals receives USFDA approval for Sumatriptan single-dose autoinjector
The product marks Alembic’s first drug–device combination to be approved in the United States