DynaGen Receives Its First FDA Abbreviated New Drug Application -ANDA- Approval for Generic Version of Lomotil; Lomotil Generic Market Estimated at $36 Million.

Business Editors/Health & Medical Writers

WALTHAM, Mass.--(BUSINESS WIRE)--Nov. 30, 2000

DynaGen, Inc. (OTCBB:DYGN)(BSE:DYGN) today announced its wholly-owned subsidiary, Able Laboratories, has received its first Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Diphenoxylate HCI with Altropine Sulfate Tablets, 2.5 mg/0.025mg, the generic equivalent of G.D. Searle's Lomotil(R). IMS Data estimates the generic market for DynaGen's newly approved drug to be $36 million.

DynaGen filed its ANDA for Diphenoxylate HCI with Altropine Sulfate Tablets, 2.5 mg/0.025mg, in November 1999. Manufacturing of the product will begin immediately at Able Laboratories and the Company anticipates shipment of the product to commence within three weeks.

"This approval is a major event for DynaGen," stated C. Robert Cusick, chairman and chief executive officer of DynaGen, Inc. "This is our first ANDA approval and it confirms our ability to not only develop new generic drugs but to guide them through the FDA filing process. Over the past thirteen months, we have completed eleven ANDA filings. Over the past two years, we have made a significant investment in R&D because we firmly believe it is a critical component of our long-term success. Our R&D efforts have created a valuable pipeline of products pending FDA approval," continued Cusick. "DynaGen is focused on our generic drug development and manufacturing and, in addition to our existing and new products, we will continue to intensify our R&D efforts and continually feed our new product pipeline."

In order to manufacture a generic drug, a company must seek FDA approval through an abbreviated new drug application or ANDA. Under the ANDA filing procedure, the FDA typically requires the applicant to submit data illustrating that the generic drug formulation is "bioequivalent" to a previously approved drug. "Bioequivalence" means that the rate of absorption and the levels of concentration of a generic drug in the body needed to produce a therapeutic effect are substantially equivalent to those of the brand drug. The ANDA approval process typically takes twelve to eighteen months from the filing date and can cost between $500,000 to $1.5 million per product.

DynaGen, Inc., is a rapidly growing developer and manufacturer of generic pharmaceuticals. The focus of the Company is to develop products that offer attractive market opportunities within selected niche markets of the generic drug industry. DynaGen currently is selling five products and has just received an FDA ANDA approval for the genetic equivalent of Lomotil(R). In addition, the Company has eleven products in various stages of FDA approval. DynaGen's drug development program contains many diverse and dynamic products. The company is currently divesting its distribution operation to focus on development and manufacturing. As part of the Company's commitment to its new strategic focus, the Company will change its name from DynaGen, Inc. to Able Laboratories, Inc. shortly.

The Private Securities Litigation Reform Act of 1955 provides a "safe harbor" for forward-looking Statements. Certain information included in this news release (as well as information included in oral statements of other written statements made or to be made by DynaGen, Inc./Able Laboratories) contain statements that are forward-looking, such statements related to anticipated future revenues of the companies, success of current product offerings, research and development efforts and the timeliness of Federal Drug Administration (FDA) filings and approvals. There is no assurance that the company will achieve the sales levels that will make the operation profitable or that FDA filings and approvals will be completed as anticipated. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future and accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of DynaGen, Inc./Able Laboratories. For a description of additional risks, and uncertainties, please refer to DynaGen, Inc. or Able Laboratories, filings with the Securities and Exchange Commission, including Forms 10K and 10Q.

Lomotil is a registered trademark of G.D. Searle & Co.