Drugs

AstraZeneca Petition Seeks to Block Cipla's Generic Lynparza

AstraZeneca has petitioned FDA to withhold approval of a Cipla ANDA for proposed new strengths of generic Lynparza (olaparib) tablets unless the generic company provides additional evidence addressing formulation differences, tablet size and potential medication errors. Lynparza, a PARP inhibitor approved for certain ovarian, breast, pancreatic and prostate cancers, is currently marketed in 100 mg and 150 mg tablet strengths.

In a just-posted citizen petition, AstraZeneca argues that Cipla's proposed 200 mg, 250 mg and 300 mg tablets could raise safety and effectiveness concerns because they reportedly omit copovidone, a polymer used in the approved Lynparza formulation.

AstraZeneca contends that eliminating copovidone could affect olaparib's dissolution, stability and bioavailability. It cites FDA's August 2026 draft product-specific guidance, which identifies the polymer used in olaparib's solid dispersion as a critical excipient.

The brand company wants the agency to require comparative dissolution studies, stability data, evidence that the drug maintains its amorphous state during manufacturing and storage, and physiologically based biopharmaceutics modeling.

AstraZeneca also raises concerns that higher-strength tablets could be more difficult to swallow and that introducing three additional strengths could increase medication errors, particularly when patients undergo dose reductions. The petition asks FDA to require a formal medication-error risk assessment, including simulated-use testing, before approving Cipla's application.

Additionally, AstraZeneca argues that if the formulation changes or medication-error risks require new clinical investigations or significant labeling modifications, FDA should determine that the ANDA pathway is inappropriate.

Multiple Violations at Pritam International

A 6/2-6/6 FDA inspection at the Pritam International Private Limited drug manufacturing facility in Uttarakhand, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/27 Warning Letter says the agency also determined that the firm contract manufactures an over-the-

ICH M15 Model Evaluation Flexibility, Submission Requirements

Drug sponsors are not required to submit model analysis plans in advance under the new ICH M15 guideline on model-informed drug development (MIDD), and models that fail to meet predefined validation criteria are not necessarily disqualified from supporting regulatory decisions, international regulatory experts said during an 10/29 FDA-

FDA's Ad/Promo Enforcement Surge Undercutting Deterrent Effect: Attorneys

FDA's stepped-up enforcement against prescription drug advertising may be having an unintended consequence: Some pharmaceutical companies are becoming more willing to accept promotional risks because the agency has issued so many enforcement letters without consistently escalating to more serious actions, attorneys said during a recent Food and

Study Finds Declining FDA Advisory Committee Use, Conflict Concerns

FDA's use of advisory committees has declined since 2010, while recent research suggests financial conflicts of interest among committee members have increased after an earlier decline, according to a systematic review published in the 10/29 JAMA Network Open. Researchers from Yale University and other institutions examined 146

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Multiple Violations at Pritam International

ICH M15 Model Evaluation Flexibility, Submission Requirements

FDA's Ad/Promo Enforcement Surge Undercutting Deterrent Effect: Attorneys

Study Finds Declining FDA Advisory Committee Use, Conflict Concerns