Remove Branding Remove FDA Approval Remove Licensing Remove Packaging
article thumbnail

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. He went to our site to discover that brand-name Livalo ( pitavastatin ). and arguably just as safe.

article thumbnail

FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Pharmacy Checkers

It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. The discussion below applies to brand-name (not generic) drugs. After all, they are either “FDA-approved” or not.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. Part J is written in three sections.

article thumbnail

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

When it comes to the approval of new drugs, brand and generic, the systems of the U.S. The two agencies almost always agree on which drugs should be approved, although there is some dialog of a potential growing divergence. drug regulatory system, see: How FDA Approves Drugs and Regulates Their Safety and Effectiveness.

Drugs 71
article thumbnail

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

The Pharma Data

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. Oncology and Hematology. Regulatory. Regulatory.

article thumbnail

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. LUMAKRAS received accelerated approval based on overall response rate and duration of response. In the U.S., Otezla continued to maintain first-line share leadership in psoriasis.

Sales 52