alembic pharma

Alembic Pharmaceuticals Ltd said on Friday that the US Food and Drug Administration has given its generic Vortioxetine tablets preliminary clearance for the treatment of major depressive disorder.

The tentative approval granted by the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Vortioxetine tablets of strengths in 5 mg, 10 mg, 15 mg and 20 mg, the company said in a statement.

These are therapeutically equivalent to the reference listed drug product (RLD) Trintellix tablets 5 mg, 10 mg, 15 mg, and 20 mg of Takeda Pharmaceuticals, USA, Inc, it added. Citing IQVIA data, the company said.

These Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021. Citing IQVIA data, the company said these Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021.

Alembic, however, said it is currently in litigation with H Lundbeck in the Court of appeals for the Federal Circuit and the launch of the product will depend on litigation outcome.

“It is possible that our ANDA may not be indicated for certain uses due to unexpired exclusivities for the RLD for such uses,” the company said.

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Erlotinib Tablets, 25 mg, 100 mg, and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tarceva Tablets, 25 mg, 100 mg, and 150 mg, of OSI Pharmaceuticals.

Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Erlotinib Tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Erlotinib Tablets, 25 mg, 100 mg, and 150 mg, have an estimated market size of $37 million for twelve months ending March 2021 according to IQVIA.

Alembic has a cumulative total of 148 ANDA approvals (130 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Macrodantin Capsules, 25 mg, 50 mg, and 100 mg, of Alvogen Malta Operations. Nitrofurantoin capsules, USP (Macrocrystals) is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.

Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg have an estimated market size of $ 23 million for twelve months ending March 2021 according to IQVIA.

Alembic has a cumulative total of 146 ANDA approvals (128 final approvals and 18 tentative approvals) from USFDA.