Company

Product

Description

Indication

Ruling

Advanced Tissue Sciences Inc. and Smith & Nephew plc (U.K.)

Dermagraft

Human tissue-engineered replacement for dermal layer of skin (viable human dermal fibroblasts cultured on bioresorbable scaffold)

Wound healing in diabetic foot ulcers

FDA notified companies that PMA not approvable without supportive data from additional controlled clinical trial; FDA also suggested that companies submit a treatment investigational device exemption (6/11)

Anika Therapeutics Inc. and Zimmer Inc. (subsidiary of Bristol-Myers Squibb Co.; NYSE:BMY)

Orthovisc

High-molecular-weight, naturally derived form of hyaluronic acid

Osteoarthritis of the knee

FDA sent company a letter stating that PMA is not approvable; additional clinical data required to show effectiveness (10/19)

Avanir Pharmaceuticals

Docosanol (a.k.a. Lidakol)

Long chain alcohol designed to interfere with virus entry into cells

Treatment of oral-facial herpes

FDA sent company a letter saying NDA is not approvable; additional clinical trial may substantiate efficacy (12/23)

Bio-Technology General Corp.

Androtab-SL (a.k.a. Androtest-SL)

Sublingual delivery system for testosterone (produces pulse-like increases in levels of hormone in blood)

Treatment of hypogonadism (testosterone deficiency) in males

FDA notified company that data submitted with NDA are inadequate for approval (1/28)

DepoTech Corp. and Chiron Corp.

DepoCyt

Injectable, sustained-release formulation of chemotherapeutic drug cytarabine (uses Depo-Foam lipid-based drug delivery)

Neoplastic meningitis arising from solid tumors

FDA sent company a nonapprovable letter, saying the product failed to decisively prove patient benefit; FDA also said that data are sufficiently promising to support submission of treatment IND for this indication (5/26)

Ergo Science Corp.

Ergoset Tablets

Low-dose, oral formulation of bromocriptine (ergot alkaloid; generic dopamine agonist)

Type II diabetes (monotherapy as adjunct to diet to improve glycemic control in diabetics)

FDA sent company a nonapprovable letter, citing unfavorable risk/benefit ratio (11/23)

Matritech Inc.

NuMA Test Kit

Diagnostic blood test that detects a nuclear matrix protein present at elevated levels in colon cancer cells

Aid in monitoring and management of patients diagnosed with colon cancer

FDA said that product does not meet its criteria for 510(k) marketing clearance (5/19)

Texas Biotechnology Corp. and SmithKline Beecham plc (NYSE: SBH; U.K.)

Novastan

Synthetic small molecule (argatroban) derived from arginine; acts as direct inhibitor of thrombin

Anticoagulant therapy in patients with heparin-induced thrombocytopenia

FDA sent company a non-approvable letter (drug was not studied in comparison to placebo) (5/11)


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