FDA Approval Activities for this Drug…

Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S054 9/5/03 9/25/03 9/25/03 Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S052 10/29/02 11/18/02 10/29/02 Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S050 7/12/02 7/15/02 7/12/02 Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S042 6/22/01 11/6/01 11/6/01 Pravachol/Pravastatin Sodium Tablets, Bristol-Myers Squibb NDA 19-898/S034 10/14/99 10/15/99 2/22/00 Pravachol (pravastatin) Tablets, Bristol-Myers Squibb NDA 19-898/S-032 2/10/00 2/14/00 12/11/01 Pravachol Indications: This supplemental new drug application provides for a new indication, based on the results of the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study, for the use of pravastatin in patients with evident coronary heart disease to reduce the risk of total mortality by reducing coronary death. In addition, this supplemental application provides for changes to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the Pravachol package insert. Pravachol (pravastatin) Tablets,Rx Bristol-Myers Squibb NDA 19-898/S-031 6/9/00 6/12/00 Pravachol Indications: This supplemental new drug application provides for the additional indication of increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb). Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S018 3/27/98 5/22/01 Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb NDA 19-898/S020 3/11/98 5/22/01 Pravachol/Pravastatin Sodium Tablets, Bristol-Myers Squibb 19-898/S026, S027, S029, S030 1/18/00 1/21/00 Pravachol/Pravastatin Sodium Tablets, Bristol-Myers Squibb 19-898/S026, S027, S029, S030 1/18/00 1/21/00 Pravachol Indications: These supplemental new drug applications provide for new indications for the use of Pravachol (pravastatin) tablets in the treatment of patients with Frederickson Type IV (S-026) and in the treatment of patients with Frederickson Type III (S-027). In addition, they provide for an optional starting dose of 40 mg/day (S-029) and for a change in the recommended time of dosing from administration at bedtime to administration at any time of day with or without food (S-030). 5. It is a prescription drug. Pravachol (Pravastatin) Tablets, Bristol-Myers Squibb 19-898/S034 10/14/99 7/6/00 Pravachol (Pravastatin) Tablets, Bristol-Myers Squibb 19-898/S037 6/23/00 Pravachol Indications: Change to the Clinical Pharmacology, Pharmacokinetics/Metabolism subsection regarding age-relatd differences in mean AUC and mean cumulative urinary excretion of pravastatin and for the addition of a "Geriatric Use" subsection to the Precautions section of the Provachol package insert. Pravachol (Pravastatin) Tablets, Bristol-Myers Squibb 19-898/S046 12/18/01 5/1/02 1/25/02 Pravastatin Sodium Tablets, 10, 20 40 & 80 mg, Ranbaxy ANDA 76-445 9/30/03 Pravastatin Sodium Tablets, 10, 20 & 40 mg, LEK ANDA 76-397 6/26/03 Pravastatin Sodium Tablets, 10, 20 & 40 mg, Apotex ANDA 76-341 9/30/03 Pravastatin Sodium Tablets, 10, 20, 40 & 80 mg, Geneva ANDA 76-279 1/30/03 Pravastatin Sodium Tablets, 10, 20 & 40 mg, Ivax ANDA 76-199 7/31/03 Pravastatin Sodium Tablets, 10, 20 & 40 mg, Teva ANDA 76-056 Pravigard PAC (co-packaged 20, 40 or 80 mg pravastatin sodium and 81 or 325 mg buffered aspirin) Tablets, Bristol-Myers Squibb Company NDA 21-387

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