STERANE (nda009996)- (5MG)

Generic Name	PREDNISOLONE	Innovator	PFIZER
Dosage	5MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	STERANE is indicated for: 1. Endocrine disorders *Congenital adrenal hyperplasia *Nonsuppurative thyroiditis *Hypercalcemia associated with cancer 2. Rheumatic disorders *Psoriatic arthritis *Rheumatoid arthritis; including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) *Ankylosing spondylitis *Acute and subacute bursitis *Acute nonspecific tenosynovitis *Acute gouty arthritis *Post-traumatic osteoarthritis *Synovitis of osteoarthritis *Epicondylitis 3. Collagen diseases *Systemic lupus erythematosus *Acute rheumatic carditis *Systemic dermatomyositis (polymyositis) 4. Dermatologic diseases *Pemphigus *Bullous dermatitis herpetiformis *Severe erythema multiforme (Stevens-Johnson syndrome) *Exfoliative dermatitis *Mycosis fungoides *Severe psoriasis *Severe seborrheic dermatitis 5. Allergic states *Seasonal or perennial allergic rhinitis *Serum sickness *Bronchial asthma *Contact dermatitis *Atopic dermatitis *Drug hypersensitivity reactions 6. Ophthalmic diseases *Allergic conjunctivitis *Keratitis *Allergic corneal marginal ulcers *Herpes zoster ophthalmicus *Iritis and iridocyclitis *Chorioretinitis *Anterior segment inflammation *Diffuse posterior uveitis and choroiditis *Optic neuritis *Sympathetic ophthalmia 7. Respiratory diseases *Symptomatic sarcoidosis *Loeffler's syndrome not manageable by other means *Berylliosis *Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy *Aspiration pneumonitis 8. Hematologic disorders *Idiopathic thrombocytopenic purpura in adults *Secondary thrombocytopenia in adults *Acquired (autoimmune) hemolytic anemia *Erythroblastopenia (RBC anemia) *Congenital (erythroid) hypoplastic anemia 9. Neoplastic diseases *Leukemias and lymphomas in adults *Acute leukemia of childhood 10. Edematous states 11. Gastrointestinal diseases *Ulcerative colitis *Regional enteritis 12. Nervous system *Acute exacerbations of multiple sclerosis 13. Miscellaneous *Tuberculous meningitis with sub-arachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
5MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of STERANE