Drug Approval | May 12, 2025
Zydus receives final approval from USFDA for Glatiramer Acetate Injection
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
Topiramate is indicated as a treatment of epilepsy and migraine
The portfolio consists of liquids and immediate release solid orals which are in the therapeutic segment to treat infections associated with UTIs
Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,
Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
According to IQVIATM sales data for the 12-month period ending February 2025, the Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market3 achieved annual sales of approximately $421.7 million.
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