Corporate News     03-Jul-24
Alembic Pharmaceuticals receives USFDA approval (final & tentative) for 11 products

Alembic Pharmaceuticals has received 11 US Food & Drug Administration (USFDA) Product Approvals (Final & Tentative) during the quarter ended 30 June 2024. The products and indication is summarized as under:

Clindamycin Phosphate Topical Gel USP 1% Clindamycin phosphate gel is indicated in the treatment of acne vulgaris.
Diazepam Injection USP, 10mg/2mL (5 mg/mL), Single-Dose Prefilled Syringe Diazepam Injection USP Diazepam is indicated for the management of anxiety disorders or for the shortterm relief of the symptoms of anxiety. 
Selexipag Tablets 1,000mcg and 1,200mcg. Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
Binimetinib Tablets 15mg Binimetinib tablet is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
Tretinoin Cream USP, 0.1%, Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris.
Sacubitril and Valsartan Tablets, 24mg/26mg, 49mg/51mg, and 97mg/103 mg. Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. It is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older.
Methotrexate Tablets USP, 2.5mg Methotrexate Tablets are indicated for the treatment of neoplastic diseases, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis.
Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5mg, 75mg, and 150mg. Venlafaxine Hydrochloride Extended-Release Capsules are indicated for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder.
Icatibant Injection, 30mg/3 mL (10 mg/mL) Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Dabigatran Etexilate Capsules, 75mg and 150mg Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients.
Dabigatran Etexilate Capsules, 110mg Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients
Doxycycline Capsules, 40mg. Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Bosutinib Tablets, 100mg and 500mg Bosutinib tablets are indicated for the treatment of adult patients with a certain type of leukemia called Philadelphia chromosomepositive chronic myelogenous leukemia. 
Previous News
  Alembic Pharma Q3 PAT slips 29% YoY; R&D spend at Rs 157 crore
 ( Hot Pursuit - 02-Feb-23   10:41 )
  Volumes jump at Alembic Pharmaceuticals Ltd counter
 ( Hot Pursuit - 21-Feb-23   11:00 )
  Alembic Pharma's Panelav facility gets EIR from USFDA
 ( Hot Pursuit - 09-Dec-22   14:23 )
  Alembic Pharmaceuticals to table results
 ( Corporate News - 22-Jul-23   11:01 )
  Alembic Pharmaceuticals to convene board meeting
 ( Corporate News - 18-Jan-23   10:51 )
  Aleor Dermaceuticals receives USFDA approval for Lidocaine 2.5% and Prilocaine 2.5% Cream
 ( Corporate News - 12-Apr-22   10:20 )
  Alembic Pharmaceuticals update on its Namthang facility in Sikkim
 ( Corporate News - 04-Oct-23   14:52 )
  Alembic Pharmaceuticals receives USFDA approval for Clarithromycin Tablets
 ( Corporate News - 01-Feb-22   10:52 )
  Alembic Pharmaceuticals receives USFDA approval for Desipramine Hydrochloride Tablets
 ( Corporate News - 08-Jul-21   10:25 )
  Alembic Pharma suspends Sikkim facility operations due to floods
 ( Hot Pursuit - 04-Oct-23   14:39 )
  Intellect Design Arena Ltd leads losers in 'A' group
 ( Hot Pursuit - 10-May-24   15:00 )
Other Stories
  Board of Delhivery approves alteration in capital clause of MoA
  05-Jul-24   19:32
  J B Chemicals & Pharmaceuticals appoints director
  05-Jul-24   19:30
  Infosys announces resignation of senior management personnel
  05-Jul-24   19:22
  JLR Q1 FY25 retail sales up 9% on YoY basis
  05-Jul-24   19:08
  Bajaj Auto launches world's first CNG motorcycle 'Freedom'
  05-Jul-24   18:59
  Agenda for board meeting of Power Grid Corporation of India
  05-Jul-24   18:46
  Board of Bank of Baroda approves raising additional capital up to Rs 7,500 cr in FY25
  05-Jul-24   18:06
  Vipul to hold board meeting
  05-Jul-24   17:15
  Markobenz Ventures to convene board meeting
  05-Jul-24   17:15
  Dhanashree Electronics to declare Quarterly Result
  05-Jul-24   17:15
Back Top