Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal ODT Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline LLC.
Lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for: i) partial-onset seizures, ii) primary generalized tonic-clonic (PGTC) seizures, and iii) generalized seizures of Lennox Gastaut syndrome. It is also indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg, have an estimated market size of US$ 27 million for twelve months ending December 2025 according to IQVIA.
Aurobindo Pharma announced that its wholly owned subsidiary, Eugia Pharma Specialities, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Everolimus Tablets, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zortress Tablets, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, of Novartis Pharmaceuticals Corp.
This approval has been received from Eugia Unit-I and is expected to be launched in Q1FY27.
The approved product has an estimated market size of US$ 78 million for the twelve months ending December 2025, according to IQVIA MAT.
This is the 184th ANDA approval (including 10 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Everolimus Tablets are Indicated for the prophylaxis of organ rejection in adult patients (i) Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (ii) Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids.
This is the next phase of our journey post the onboarding onto the NATO supply chain & commercialisation of our empty shell line, said the company.
The said agreement covers the complete large caliber ammunition category starting with 155 mm M107, 152 mm & 155 mm ERFB/BT variants & will be extended to 105 mm, 120 mm, 81 mm amongst others.
Product details:
155 mm M107: 30,000 units per month in ‘Ready to Fill' condition for a period of 5 years 152 mm: 10,000 units per month in ‘Ready to Fill' condition for a period of 5 years
Pricing details:
155 mm M107: USD 315 per unit 152 mm: USD 315 per unit