Generic Product News February 2023

Pharmacy TimesFebruary 2023
Volume 89
Issue 2

Products range from Parkinson disease treatment to medication for epilepsy.

Carbidopa and Levodopa USP Tablets 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg

From: Aurobindo Pharma Limited

Compare To: Sinemet

The FDA has approved Aurobindo Pharma Limited’s abbreviated new drug application for carbidopa and levodopa tablets in doses of 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg. Carbidopa and levodopa tablets are an AB-rated generic that is equivalent to the reference listed drug, Sinemet tablets from Organon. Carbidopa and levodopa tablets are indicated to treat Parkinson disease, postencephalitic parkinsonism, and symptomatic parkinsonism. Symptomatic parkinsonism may follow intoxication from carbon monoxide or manganese.

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Extended Phenytoin Sodium Capsules USP, 100 mg

From: Unichem Laboratories Limited

Compare To: Dilantin Capsules, 100 mg

The FDA has approved an abbreviated new drug application for Unichem Laboratories Limited’s extended phenytoin sodium capsules USP, 100 mg. Extended phenytoin sodium capsules are the generic of reference drug Dilantin, marketed by Viatris Inc. The generic drug is indicated to treat psychomotor (temporal lobe) tonic-clonic (grand mal) seizures. It is also indicated to prevent and treat seizures during or after surgery. The capsules should be taken 3 times daily, adjusting by 2 to 3 capsules if needed. The most common adverse events of the reference drug are nervous system reactions such as ataxia, decreased coordination, mental confusion, nystagmus, slurred speech, decreased coordination, and mental confusion.

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Tolvaptan Tablets, 15 mg

From: Camber Pharmaceuticals

Compare To: Samsca

Camber Pharmaceuticals now offers tolvaptan tablets, the generic of Samsca from Otsuka Pharmaceutical Co, Ltd. Tolvaptan tablets are indicated to treat hyponatremia, or low levels of blood sodium. This condition often occurs in patients who have experienced heart failure. The new generic tablets are also indicated for the treatment of certain types of hormonal imbalances. The 15-mg tolvaptan tablets are available in a 10 (1 × 10) unit-dose blister pack. The most common adverse events when taking this generic include constipation, dry mouth, frequent urination, increased blood glucose levels, thirst, and weakness.

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Topiramate Extended-Release Capsules, 25, 50,and 100 mg

From: Zydus Pharmaceuticals Inc

Compare To: Qudexy XR

The FDA has approved topiramate extended-release capsules in doses of 25, 50, and 100 mg to treat various forms of epilepsy. Topiramate extended-release capsules are a product of Zydus Pharmaceuticals Inc, a subsidiary of Zydus Lifesciences Limited, and are a generic for Qudexy XR, by Upsher-Smith Laboratories, LLC. The capsules can be used for patients aged 6 years and older as an initial monotherapy for partial-onset or primary generalized tonic-clonic seizures. The agent can also be used as an adjunctive therapy for patients 6 years and older with partial-onset, primary generalized tonic-clonic seizures, and those with seizures associated with Lennox-Gastaut syndrome. It is further indicated for patients aged 12 and older for prophylaxis of migraine. Zydus is the first company to receive FDA approval and launch the allotted doses of topiramate extended-release capsules in the United States. The annual sales for topiramate extended-release capsules are $488 million in the United States, according to data from IQVIA.

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