Alembic Pharma gets USFDA nod for Fluorouracil Injection USP, 2.5 g/50 mL pharmacy bulk vial
It is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric…
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ANDA approval
Zydus gets final US FDA approval for Vigabatrin for Oral Solution USP, 500 mg
Vigabatrin for oral solution is indicated for the treatment of refractory complex partial seizures as adjunctive therapy in…
Alembic Pharma gets USFDA nod for Docetaxel Injection USP
Docetaxcel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric…
Glenmark gets second tentative ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg
Glenmark’s first tentative approval letter for Saxagliptin Tablets, 2.5 mg and 5 mg was received on June 12, 2017
Glenmark gets ANDA approval for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg
Nicardipine tablets are indicated for the treatment of high blood pressure and to control angina (chest pain)
Glenmark gets US FDA nod for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous…
These capsules are given to prevent pregnancy
Pricing pressures, regulatory scrutiny prevail in US generics pharma industry: ICRA
ICRA expects mid to high single-digit price erosion to continue to exert pressure over the near term, resulting in muted revenue…
Lupin gets approval from US FDA for Azilsartan Medoxomil Tablets
The product will be manufactured at Lupin’s facility in Nagpur, India.
NATCO gets ANDA approval for Cabazitaxel Intravenous Solution
Breckenridge and Natco did not divulge any more details regarding the launch date for the product
Glenmark Pharma receives ANDA approval for Abiraterone Acetate tablets USP, 500 mg
The tablets are a generic version of Zytiga Tablets, 500 mg, of Janssen Biotech