|
Exclusivity Start Date
|
Generic Name
|
Trade Name
|
Indication for Original Approvala
|
|
3/22/94
|
Pilocarpineb,d
|
Salagen
|
Treatment of symptoms of xerostomia from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck
|
|
5/31/94
|
Rifampin, isoniazid, pyrazinamide
|
Rifater
|
For the short-course treatment of tuberculosis
|
|
6/30/94
|
Aminosalicylic acid
|
Paser granules
|
Treatment of tuberculosis infections
|
|
7/29/94
|
Sulfadiazineb
|
N/A
|
Toxoplasmosis, as adjunctive with pyrimethamine
|
|
8/15/94
|
Cysteamine
|
Cystagon
|
Treatment of nephropathic cystinosis in adults and children
|
|
8/3/95
|
Amiodarone HClb
|
Cordarone
|
For initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy
|
|
11/22/95
|
Tretinoinb,d
|
Vesanoid
|
Induction of remission in patients with acute promyelocytic leukemia who are refractory to or unable to tolerate anthracycline-based cytotoxic chemotherapeutic regimens
|
|
12/12/95
|
Riluzoleb,d
|
Rilutek
|
Treatment of patients with amyotrophic lateral sclerosis
|
|
4/30/96
|
Sodium phenylbutyrated
|
Buphenyl
|
Adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase
|
|
5/17/96
|
Interferon beta-1ac,e
|
Avonex
|
Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations
|
|
5/17/96
|
Allopurinol sodiumb,c
|
Aloprim for injection
|
Management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy that causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy
|
|
5/22/96
|
Ofloxacinb
|
Ocuflox ophthalmic solution
|
Treatment of bacterial corneal ulcers
|