The Top Pharmaceutical Companies in the U.S.
Get just the facts on revenues and workforces for Johnson & Johnson, Pfizer and other major drugmakers based in the United States.
Approvals of FDA-Regulated Products
Go directly to the webpage where the U.S. Food and Drug Administration posts information about newly approved and licensed medications, biopharmaceuticals, medical devices, veterinary drugs and food additives.
The Food & Drug Administration
Find out how the FDA is organized and what products the federal agency regulates.
The FDA Drug Approval Process
Get an overview of how brand name, generic and OTC pharmaceutical products are approved for sale and use in U.S. pharmacies, clinics, hospitals and nursing homes.
What Are Active Pharmaceutical Ingredients, or APIs?
Chemical plants in China and India produce many of the bulk pharmaceuticals used around the world.
Brand Name Drugs
This detailed definition and description of branded pharmaceutical products also address why the medications often come at a high price for patients.
Over-the-Counter Medicines (OTC Medicines)
OTC remedies contain FDA-regulated active pharmaceutical ingredients, but patients can purchase the medications without a presenting a prescription.
How Are OTC Drug Ads Regulated? Does It Matter?
Companies that market over-the-counter drugs tend to include fewer warning in advertising than do prescription drug manufacturers.
What Are Generic Drugs?
Nonbranded prescription pharmaceutical products are therapeutically equivalent copies of brand name medications that usually cost much less than innovator drugs.
Generic Drug Trends: Are We Headed for an All-Generic Drug Pharmacopeia?
Since the Hatch-Waxman Act took effect in 1984, utilization of generic prescription medications in the United States has grown steadily. New federal laws create a pathway for licensing biosimilar products.
Authorized Generics: An Overview
The Generic Pharmaceutical Association argues that low-cost, unbranded versions of brand name drugs produced by the same companies that make the innovator products skew the market for generic drugs.
Authorized Generics: The Lowdown
Some generic drugmakers and consumer advocates contend authorized generics are just brand name pharmaceutical products disguised as lower-cost alternatives to branded drugs.
Indian Generic Companies
What does the growing presence of unbranded medications produced in India mean for health care and patients in the United States.
Introducing follow-on biotech drugs has proven difficult and controversial.
Biogenerics: GPhA's Stand
The Generic Pharmaceutical Association, the leading organization for companies that make unbranded drugs, supports the licensing, prescribing and sale of follow-on biologic drugs.
Biosimilars and Obamacare: A Role for Pharmacists FAQ
Pharmacists have essential roles to play in ensuring patients get the greatest health benefits from biosimilars and that insurers realize the greatest savings with follow-on biologics.
How Does FDA Regulate Drug Compounding by Pharmacies?
The U.S. Food and Drug Administration has authority to regulate pharmacies and pharmacists that prepare compounded medications. The rules regarding whether pharmacy-made compounded drugs must be approved by the agency and labeled in accordance with FDA regulations differ from those enforced for pharmaceutical manufacturers, however. A key...