Generic Drugs

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.

Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

The guidance explains the process of applying for competitive generic therapy designation.

C-Bridge Capital will form a new biopharmaceutical company, AffaMed Therapeutics, which will collaborate with Samsung Bioepis to accelerate clinical development and registration of Samsung Bioepis’ next-generation biosimilars in China.

The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs.

The US and pharmerging markets will drive growth in drug spending; number of approvals to increase.

Teva Pharmaceuticals and Neos Therapeutics entered into a settlement and licensing agreement to resolve all ongoing litigation involving Neos' patents protecting its Cotempla (methylphenidate) extended-release orally disintegrating tablets.

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.

Irish manufacturer of generic medicines for both human and animal health, Chanelle Pharma, has been named as Pharma Industry Company of the Year 2018.

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

More than 120 healthcare organizations plan to bring competition to generic drug market.

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

The approval is intended to increase patient access to treatment for opioid addiction.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

Internationalization and regulatory reform are driving growth and investment China.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.