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



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