Cipla Secures USFDA Approval to Launch Generic Cancer Drug in the US

Gains Nod for Generic Version of Abraxane; Launch Expected in H1 FY26​

New Delhi, April 11 – Pharmaceutical giant Cipla announced on Friday that it has received final approval from the United States Food and Drug Administration (USFDA) to market its generic version of a widely used cancer treatment drug in the United States.

The approval pertains to Cipla’s Abbreviated New Drug Application (ANDA) for paclitaxel protein-bound particles for injectable suspension (albumin-bound), 100 mg/vial, a single-dose formulation. This marks a significant milestone for the Mumbai-based drugmaker as it prepares to enter the US oncology segment with a cost-effective alternative.

Cipla’s approved product is a therapeutic equivalent to Bristol Myers Squibb’s Abraxane, a branded formulation used in the treatment of multiple cancers.

Indications and Market Launch Timeline​

Paclitaxel protein-bound is used in the treatment of:

• Metastatic breast cancer
• Locally advanced or metastatic non-small cell lung cancer (NSCLC)
• Metastatic adenocarcinoma of the pancreas

Cipla stated that the launch of the product is scheduled for the first half of the current financial year in the United States, signaling an imminent commercial rollout.

Market Reaction​

Following the announcement, Cipla’s shares showed positive momentum, rising by 2.73% to ₹1,454.90 apiece on the Bombay Stock Exchange (BSE).

The development reinforces Cipla’s growing footprint in the US generics market, particularly in the high-value oncology space, where demand for affordable treatment alternatives continues to surge.