Alembic Partner Natco Pharma Receives US FDA Tentative Approval for Olaparib Tablets
Product to be manufactured by Natco Pharma and distributed by Alembic Pharmaceuticals in the US
Alembic Pharmaceuticals Limited announced that its partner Natco Pharma Limited has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for olaparib tablets in 100 mg and 150 mg strengths.
The approval covers a generic version of Lynparza tablets, which is marketed by AstraZeneca Pharmaceuticals LP. The approved olaparib tablets are considered therapeutically equivalent to the reference listed drug (RLD) for the indications included in the approved labeling.
Olaparib Tablets Receive Tentative US FDA Approval
The US FDA's tentative approval allows Natco Pharma to move forward with its generic olaparib tablets, subject to the applicable regulatory and legal requirements.
The approved strengths include:
- Olaparib tablets, 100 mg
- Olaparib tablets, 150 mg
Olaparib is the generic version of Lynparza tablets, 100 mg and 150 mg, developed and marketed by AstraZeneca.
The product is approved for the indications covered under the approved labeling of the reference listed drug.
Natco to Manufacture and Alembic to Distribute the Product
Under the partnership arrangement, Natco Pharma will be responsible for manufacturing olaparib tablets for the US market.
Alembic Pharmaceuticals will handle the distribution of the product in the United States.
The partnership allows the two companies to combine their respective capabilities, with Natco taking responsibility for manufacturing and Alembic supporting the commercial distribution of the product in the US market.
Para IV Litigation Remains Ongoing
The companies also stated that Para IV litigation related to the product is currently ongoing.
A Paragraph IV certification is used in the US generic drug approval process when a generic drug applicant challenges certain patents listed for the reference product. Such legal proceedings can affect when a generic product may be commercially launched.
The tentative FDA approval therefore does not by itself indicate an immediate commercial launch of the olaparib tablets.
Alembic's US FDA Approval Record
With this latest regulatory milestone, Alembic Pharmaceuticals has reached a cumulative total of 244 ANDA approvals from the US FDA.
This includes:
- 224 final approvals
- 20 tentative approvals
The company continues to expand its portfolio of generic pharmaceutical products for the US market through its own development activities and partnerships with other pharmaceutical companies.
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