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FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. for the treatment of diabetes. Biosimilars marketed in the U.S.

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Lilly Offers All Zepbound Doses via LillyDirect Self-Pay Pharmacy

The Pharma Data

Lilly to Expand Access to Zepbound: All Approved Doses Now Available in Vials Through LillyDirect’s Self-Pay Pharmacy Solutions Eli Lilly and Company today made a significant announcement aimed at improving patient access to its obesity treatment Zepbound (tirzepatide). Cardiometaboltic Health at Lilly.

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Economic Theory Explains Big Pharma Scare Tactics on Importation

Policy Prescription

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. Third, even foreign drug prices are much higher than the cost of production.

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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. Explain the FDA Approval Process Many patients are unaware of the rigorous approval process generic drugs must undergo. It’s always a good idea to compare prices at different pharmacies.

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Article FDA Thank You Addressing benzene contamination, FDA issues guidance for reformulating products containing certain carbomers

Agency IQ

Now, the FDA has released guidance laying out the tests and regulatory submissions needed for the reformulation of products containing these ingredients. Benzene may occur in some products from the degradation of other ingredients, increasing the risk for unintentional contamination.

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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog: Biosimilars

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. Section II at 2. Draft Guidance III.B.2(e)

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Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. The result was the addition of Section 503A to the FD&C Act.

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