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Cipla Welcomes Abraxane ANDA Approval After Tackling Goa Compliance Issues

Only Second Abraxane ANDA And Fourth ‘Therapeutic Equivalent’ To BMS Brand

 
• By Dean Rudge

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

• Source: Shutterstock

Following years of development and setbacks, Cipla has won US Food and Drug Administration approval for a generic version of Bristol Myers Squibb’s hard-to-manufacture Abraxane (protein-bound paclitaxel) – just the second Abraxane abbreviated new drug application product to receive FDA approval.

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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

Sunshine Becomes Latest To Compete On Everolimus In Canada

 
• By Dave Wallace

Sunshine Biopharma is continuing to roll out generic launches in Canada, with its latest product challenging Afinitor and other everolimus rivals in the market.

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

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Samsung Bioepis Reevaluating Approach To Biosimilars

 
• By Jessica Merrill

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.

Polpharma Looks To Supercharge Biosimilar Development With Help Of Chime

 
• By Dean Rudge

With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.

Fresenius Divests Brazilian Sites To EMS Amid Structural Streamlining

 
• By Adam Zamecnik

The divestment marks a further step in Fresenius’ ongoing strategy towards a more optimized and simplified company structure while doubling down on new endeavors in the Biopharma space.