Dosage Forms

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

The US Food and Drug Administration launched a new program to increase the number and variety of generic drugs available to the public, beginning in FY2008.

FDA Aims to Approve Record Number of Generics

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

A spate of drugs are scheduled to come off patent, offering vast potential and competition.

Favorable Outlook for Generic APIs

Michelle Hoffman, editorial director of Pharmaceutical Technology.

A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.

New FDA Guidance on Polymorphic Compounds in Generic Drugs

Double-digit growth is projected for the US generic drug market, and the industry positions for opportunities in biosimilars.

Opportunities Abound for Generic Drugs

Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).

FDA Issues Draft Guidances for Online Access of Bioequivalence Studies for Generic Drugs

Darmstadt, Germany (May 13)-Mylan Laboratories Inc. and Merck KGaA have signed a share purchase agreement under which Mylan will acquire all of Merck's worldwide operations within Merck Generics, the company?s generics business.

Merck Sells Generics Business to Mylan Labs

Rockville, MD (May 1)-The US Food and Drug Administration issued a report, "Critical Path Opportunities for Generic Drugs," to identify the scientific challenges, including those in manufacturing science, in developing generic drugs and the opportunities for collaborative solutions in resolving those challenges.

FDA Outlines Critical Path Opportunities for Generic Drugs

Washington, DC (April 30)-Less than two weeks after the Senate Health, Education, Labor, and Pensions Committee voted to reauthorize the Prescription Drug User Fee Act (PDUFA), the bill this week moved onto the Senate floor.

Senate Opens PDUFA Debate, Postpones Biogenerics Talks

Gurgaon, Haryana, India (Mar. 13)-Ranbaxy Laboratories Limited confirmed that it has made a nonbinding bid for the generic drug business of Merck KGaA.

Ranbaxy Makes Bid for Merck KGaA's Generic Drug Business

Brussels (Feb. 13)-The European Generic Medicines Association raised concerns over what it terms ?the serious lack? of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.