NEWS FROM USA
NEW PARAGRAPH IV FILING
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
Type of Submission (Based on Date) |
|
Cangrelor |
Injection |
Kengreal |
24 June 2019 |
NCE-1 |
|
Eluxadoline |
Tablets |
Viberzi |
28 May 2019 |
NCE-1 |
FDA’s updated list on Paragraph four filings is available here.
NDA SUBMISSION
Elagolix (Abbvie): AbbVie Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women.
- Abbvie announced the submission of a New Drug Application (NDA) to the UFDA for elagolix, an investigational, oral gonadotropin-releasing hormone (GnRH) antagonist, for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids in women.
- Elagolix in combination with low-dose hormone (add-back) therapy (estradiol 1.0 mg/norethindrone acetate 0.5 mg) has the potential to offer women and their healthcare providers an additional oral medical treatment option.
- Press Release: Link
NDA APPROVALS
New chemical entity approval
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Comments |
|
02 Aug 2018 |
Pexidartinib Capsule |
Daiichi Sankyo |
Turalio |
Indication: Symptomatic Tenosynovial Giant Cell Tumor (Tgct) Associated With Severe Morbidity Or Functional Limitations And Not Amenable To Improvement With Surgery
Strength: 200 Mg
|
ANDA APPROVALS
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
01 Aug 2019 |
Kinedexe Uk |
Tasmar (Bausch) |
Two (Ingenus, Par Pharma) |
|
|
01 Aug 2019 |
Bayshore Pharms |
Visken (Novartis) |
Four |
|
|
01 Aug 2019 |
Micro Labs |
Hiprex (US Pharma) |
Three |
|
|
06 Aug 2019 |
Granules pharma |
Evekeo (Arbor pharma) |
Two (Amneal, Aurolife pharma) |
TENTATIVE ANDA APPROVALS
|
Approval Date |
Drug |
Company |
|
01 Aug 2019 |
Teva Pharms |
|
|
02 Aug 2019 |
Sun Pharm |
USFDA INSPECTIONS
Lupin (Mandideep facility): France’s ANSM completes inspection at Lupin’s Mandideep facility (Unit-1)
- Lupin announced the completion of the Good Manufacturing Practices (GMP) Inspection of its finished product manufacturing facility (Unit-1) at Mandideep, by the French National Agency for Medicines and Health Products Safety (ANSM).
- The inspection was conducted between April 8, 2019 and April 12, 2019.
- The ANSM inspection closed with no critical or major observations.
- Press Release: Link
Lupin (Aurangabad facility): Lupin’s Aurangabad facility receives EIR from the U.S. FDA.
- Lupin announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Aurangabad facility.
- The facility was inspected by the U.S. FDA between May 6, 2019 and May 15, 2019.
- Press Release: Link
Natco Pharma (Kothur facility): Natco pharma receives establishment inspection report for kothur facility.
- Natco pharma announced successful closure of inspection with the receipt of Establishment Inspection Report (EIR) from the UFDA for the inspection conducted at its drug formulations facility in Kothur Village.
- The inspection was conducted between May 30, 2019 to June 5, 2019.
- Press Release: Link
NEWS FROM EUROPE:
Vinorelbine (Navelbine®) Soft gel Capsules from Alvogen and Lotus: Alvogen and Lotus announce first to launch generic version of Navelbine® softgel capsule in Europe
- The product is the generic version of Pierre Fabre Medicament’s Navelbine which is indicated for the treatment of advanced non-small-cell lung cancer (NSCLC) and advanced breast cancer.
- According to IQVIA, recorded global sales of this product was US$111 million in 2018
- Press release: Link
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